Careers

Home > Careers

Careers Banner

A Progressive and Exciting Workplace

At Acumed, the people who work here are our most valuable asset. By providing a dynamic environment that supports individual growth and responsibility, we’ve been able to hire, and retain some of the brightest minds in healthcare. We believe strongly that each of our employees makes an impact on the lives of the patients who receive our products. Which is why we encourage everyone within the company to push the limits of their expertise, whether it’s in engineering, production, inspection, marketing, or regulatory and compliance. Personal health and happiness are highly valued at Acumed, and we devote a significant amount of resources to ensure it. We provide benefits that enhance medical care, help plan for the future and promote general well being.


Acumed is currently hiring for a variety of positions. To apply for an open position, please visit our careers portal.

Benefits Include . . .

  • Generous PTO
  • Medical, Dental, and Life Insurance
  • Short and Long Term Disability Insurance
  • 401(k)
  • Nine Paid Holidays
  • Retirement Plan
  • Flexible Spending Accounts
  • Educational Assistance
  • TriMet Bus Passes
  • Reduced Costco Membership Fees
  • Reduced Gym Membership Fees
  • Credit Union Membership
  • An Employee Referral Program
  • Bike Room and Showers

Current Open Positions

Position Location Department Posted Onsort descending
Production Supervisor OR, USA Production Apr. 15, 2014

Overview

The Production Supervisor is responsible for providing leadership and support to cell members. Facilitates constructive communication and builds teamwork. Leads the cell teams toward achieving objectives for quality, delivery, and cost.

General Duties/Responsibilities

  • Primary responsibility is to provide support and direction to the cell team. This requires spending up to 40 percent of the average workday in the cell, interacting in person and building rapport with team members.
  • Work with team members to set measurable goals. Ensure that team objectives and efforts are aligned with the company's current strategies and priorities.
  • Provide training and tools team members need in order to grow professionally and achieve their goals.
  • Promote a customer focus in the cell.
  • Ensure that cell processes are managed and adhered to. Monitor key performance metrics to ensure constant improvement and waste reduction.
  • Promote and support continuous process improvement activities. Identify constraints and make sure cell members are aware of these and are working to eliminate bottlenecks.
  • Work with Process Engineers to standardize processes and maintain a smooth workflow.
  • In preparation for annual performance appraisals, follow up on progress with each cell member at least quarterly, and revisit/adjust goals as necessary.
  • Work proactively with other cells, and provide support as needed, to ensure that customer needs are met.
  • Build productive working relationships with internal and external customers (i.e. planning, quality assurance, outside vendors...)
  • Facilitate and actively participate in group team building activities.
  • Make sure that cell teams meet regularly, and provide guidance/support as needed.
  • Support new product introduction activities
  • Monitor capacity in the cell(s). Make sure they have the resources to accomplish the work in the most efficient manner possible.
  • Develop documentation to procure equipment - Authority for Expenditure (AFE) and Return on Investment (ROI).
  • Set a standard for proactive (rather than reactive) processes and decision-making.
  • Promote safety within the shop.
  • Other job related duties as assigned.

Qualifications

  • Minimum 3 years of supervising a team (preferably in a production environment), or equivalent education/ experience in a similar capacity.
  • Good supervising skills and ability to motivate others to work as a team towards a common goal
  • Excellent organizational skills with extensive knowledge of MS Office (i.e. Excel, Word, Outlook)
  • Demonstrated accountability / time management. Must follow through with commitments and adhere to deadlines.
  • Ability to read and speak English sufficiently to read, understand and complete all paperwork.
  • Knowledge of MRP system to be able to enter electronic transactions.
  • Self-motivated; able to work with little supervision.
  • Track record of developing and empowering employees.
  • Extensive knowledge of Lean Manufacturing concepts and techniques.
  • Reliable, dependable and honest.
  • Experience working in a regulated environment.
  • Knowledge of all Acumed products and processes.

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

CNC Machinist OR, USA Operations May. 22, 2014

Overview

The Operator / Machinist produces medical devices using manual and CNC equipment. (Swing shift M-Th 3:00pm-1:30am)

General Duties

  • Under general supervision, conducts the following:
  • Uses established practices to ensure Quality during operation including documentation and techniques.
  • Monitors machine performance.
  • Performs preventative maintenance as required.
  • Performs general set-ups to ensure maximum utilization.

Qualifications

  • Generally requires 1-4 years CNC equipment operating experience.
  • Swiss machine experience preferred.
  • Ability to operate machine tools safely and understand set-up instructions.
  • Familiar with basic blueprint reading or ability to acquire blueprint reading skills.
  • Familiar with basic Inspection techniques and processes, or ability to learn and understand them.
  • Basic knowledge of general manufacturing equipment.
  • Ability to follow instructions.
  • Ability to work in a team environment.
  • Basic math skills.
  • High School diploma or equivalent.
  • Ability to read and speak English sufficiently to read, understand and complete all documentation.

To apply, please visit our applicant registration page

Quality Manager OR, USA Quality Jun. 17, 2014

Overview

Provide leadership and direction in the implementation of Quality policies, procedures, and strategies, as well as prevention-based quality improvement programs.   The Quality Manager ensures that policies and procedures of the organization comply with all applicable laws and regulations.  Develop, implement, and maintain the Acumed quality system in compliance with applicable regulations.  Enhance customer satisfaction through the delivery of high-quality medical devices, promote continuous improvement culture and ensure compliance with applicable regulations. 

Duties/Responsibilities

  • Build successful teams, develop and lead people to achieve continuous quality improvement and drive change.
  • Develop and implement quality system management in alignment with the Company's long term strategy.
  • Educate non-experts, internally and externally, on complex quality topics.
  • Develop and maintain a system to measure performance against established standards.
  • Assess, report, and implement new and changing regulations or the addition of new markets to the quality system.
  • Approve post-market surveillance communications prior to submission and distribution
  • Plan and manage departmental activities in accordance with annual operating budget including capital expenditures.
  • Drive overall quality of Acumed's products and processes to ensure a satisfied customer. 
  • Ensure Acumed's products are of the highest quality, lowest risk and greatest benefit to the customer.
  • Ensure all product designs are developed in compliance with the regulations of the markets in which we sell product. 
  • Develop and maintain quality policies and ensure efficient use of Quality Engineering.
  • Assure engineering design processes and manufacturing processes are conducted in compliance with Acumed policies and procedures.
  • Ensure the health of the Acumed Quality System through:
    • Quality data analysis
    • Effective Post-Market Surveillance
    • Compliance with global adverse event/vigilance reporting requirements
    • A robust Corrective and Preventive Action (CAPA) System
    • An active and engaged Internal Audit Program
  • Host external auditors and present the Acumed Quality System in the best light. 
  • Assure all Acumed employees receive sufficient training in the elements of the Quality System and its implementation at Acumed. 
  • Ensures system is compliant with all applicable regulations including those issued by FDA, SFDA, JPAL, etc.
  • Champion the quality system management strategy within the organization to gain compliance and commitment at all levels from the executive team to the shop floor.
  • Ensure quality metrics are adequately captured, analyzed and provided to company leadership for improvement activities.  Lead Management Review activities.
  • Direct and supervise employees responsible for Document Control, Post-Market Surveillance, Corrective & Preventive Action, Field Action, Management Review, Performing Internal and Managing External Audits, and Quality System Software Validation.

Qualifications

  • Bachelor's degree in an engineering or science discipline; advanced degree preferred
  • 7-10 years of experience in medical device manufacturing
  • 5 years of experience in quality leadership role
  • Extensive knowledge of Quality System Regulation, US FDA, and ISO 13485.  Experience with international quality system regulations (JPAL, CFDA, Health Canada, ANVISA, etc) is ideal. 
  • Proven problem-solving skills and the ability to train teams to resolve various issues using available tools.
  • Familiarity with Lean Manufacturing concepts.
  • Knowledge and experience with ERP systems, preferably SAP, and its application in a quality-system environment.
  • Exceptional organizational skills with extensive knowledge of MS Office (i.e. Excel, Word, Outlook)
  • Self-motivated, able to work with little supervision.
  • Excellent leadership skills and ability to motivate others to work as a team towards a common goal, and a strong balance of strategic and tactical approaches, team building, training, coaching and development.
  • Proven success in executing improvement plans and activities that achieve expected results.
  • Strong verbal and written communication skills
  • Ability to communicate at all levels of the organization in order to influence change and drive system improvements to meet customer requirements.
  • Ability to read and speak English sufficiently to understand and complete all necessary documentation

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Packaging Engineer OR, USA Engineering Jul. 28, 2014

Overview

The Packaging Engineer is responsible for packaging, product delivery and labelling solutions for medical devices from concept to commercialization. The Packaging Engineer works closely with Product Engineering, Product Management, Quality and Supply Chain teams to produce robust and cost-effective solutions that meet market and regulatory needs. Responsibilities include implementing new packaging, product delivery solutions, maintenance of existing packaging/ product delivery solutions/ labelling, testing and validation, and effective communication with team members, management and customers.


Duties/Responsibilities
• Review draft project plans and provide feedback to ensure the plans are realistic and complete
• Research product designs, indications, intended use(s), technologies, materials.
• Create and/or develop designs for potential new product solutions and/or improved product lines, and document the design and development.
• Performs mechanical and biomechanics testing
• Create complete models, drawings, specifications, and related documents required to produce products and prototypes.
• Follows established Best Known Methods and Standards
• Conduct design verification and validation activities.
• Maintain existing solutions through championing ECO's
• Provide leadership and mentorship to junior staff including interns
• Leads small teams
• Manage multiple tasks and smaller projects
• Create draft project plans and solicit feedback to ensure the plans are realistic and complete
• Create competitive product matrices for new and/or existing product lines
• Conduct tests, write protocols and reports
• Initiates Cad Labs for internal product development
• Create new designs with moderate complexity; drawings, models, define design requirements
• Collaborates with external design partners and vendors
• Develop presentations and present clearly to internal audiences (e.g. training events)
• Communicates effectively with Sales, Field Reps, suppliers and surgeons
• Make updates/modifications to existing SOP's/ Work Instructions
• Perform Design Control activities with some supervision
• Write clinical data reports
• Review and approve drawings in ECOs
• Support Regulatory with 510(k) and Technical File support documents
• Perform market analyses, work with Product Management on ROIs
• Interfaces with manufacturing, quality, planning, regulatory, and other departments on a regular basis to determine feasibility of new project ideas/concepts/designs.
• Act as independent reviewer on other projects
• Conduct patent analyses
• Performs complex mechanical / biomechanical analyses (ex: Finite Element Analysis, etc.)
• Create designs with significant complexity
• Develop presentations and present to external audiences
• Communicates effectively and forms relationships/collaborates with Surgeons/providers/consultants/Suppliers
• Develop/refine Acumed processes (SOPs, Work Instructions, etc.)


Qualifications
• Bachelors in Mechanical Engineering, Bio-Mechanical Engineering, or Equivalent
• 2-5yrs applicable experience and demonstrated ability to perform applicable job duties
• Competency in communicating anatomy/physiology (A/P)
• Proficient with application of GD&T
• Thorough understanding of anatomy
• Working knowledge of FDA and ISO requirements related to medical devices
The Packaging Engineer is responsible for packaging, product delivery and labelling solutions for medical devices from concept to commercialization. The Packaging Engineer works closely with Product Engineering, Product Management, Quality and Supply Chain teams to produce robust and cost-effective solutions that meet market and regulatory needs. Responsibilities include implementing new packaging, product delivery solutions, maintenance of existing packaging/ product delivery solutions/ labelling, testing and validation, and effective communication with team members, management and customers.

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Director of Sales Training & Medical Education OR, USA Medical Education Jul. 30, 2014
Overview
The Director of Sales Training & Medical Education (DSTME) develops, implements and oversees administration of sales training and medical education programs which provide essential Company product knowledge, selling skills, and general business operations skills to distributors, principals, agents and the Company's field sales representatives. The DTE also develops, implements and oversees administration of medical education programs which provide Acumed's product users with information to ensure the safe and efficacious use of our products. The DSTME directs and oversees the Company's sales training and medical education teams in the development and delivery of sales and medical education programs which meet all compliance and/or regulatory requirements.


Duties/Responsibilties
• Identifies, develops, and delivers field sales training and product/medical education including sales methodology and techniques for sales associates representing Acumed product lines.
• Coordinates product-related education with Product Management for surgeons, sales representatives, and healthcare professionals that effectively prepare surgeons to use Acumed's products safely and efficaciously.
• Leverages knowledge of instructional design and compliance requirements to develop training initiatives, programs, systems, processes, tools and resources that assist field sales in developing successful sales methodologies and techniques and support/increase sales representative confidence and excitement in providing Acumed's products and solutions.
• Establishes and monitors standards and control systems for implementing and evaluating field training and medical education programs including the development of training program templates and models to ensure consistency and compliance as required.
• Drafts for executive approval a comprehensive yearly Field Training and Medical Education business plan and Needs Assessment aligned with Company's overall business plan and its strategic direction.
• In regular collaboration with Product Management teams, identifies and reassesses sales training requirements and strategies based on product progression through the product lifecycle process.
• Develops and maintains standard operating procedures regarding conducting Acumed medical educational trainings and participation in non-Acumed medical education and sales training events.
• Creates and drives performance metrics aligned with training strategy and department objectives
• Provides leadership, direction, and support to field training and medical education staff.
• Evaluates performance of staff by establishing objectives and measurements; provides constructive feedback on a regular basis.
• Manages department budget allocations within Company guidelines, always looking for cost-effective solutions which result in delivering high quality learning experiences. Provides direction regarding expense management.


Qualifications
• Bachelor's degree in Learning and Development, Instructional Design, Marketing, Biology, Business or related field
• 5-10 years of Learning and Development/Training experience
• 3-5 years of orthopedic sales or marketing experience, preferably in trauma
• Demonstrated ability to successfully develop and deliver training programs utilizing skills in instructional design, adult learning theory and various training technologies
• Excellent coaching and communication skills with ability to deliver innovative solutions and gain consensus through personal influence
• Strong organizational, planning, project management, problem resolution, communication, presentation, facilitation and leadership skills
• Excellent written and verbal communication skills; strong presentation skills, and strong project management, leadership, and team building skills
• Discretion, confidentiality and ability to build strong, trusting relationships.
• Solid understanding of global healthcare policies, trends and compliance issues.
• Proficiency in Microsoft Office, including Word, Excel, Outlook, and PowerPoint

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Vice President, Finance - CFO OR, USA Administrative Aug. 06, 2014

Position Summary

The Chief Financial Officer (CFO) will set Acumed’s financial policy and direction, reporting to and partnering with the President of Acumed and with a dual reporting relationship to the CFO of Colson Associates. The CFO will play a key role in developing, monitoring and evaluating overall corporate strategy with the President and leaders of Acumed with emphasis on bottom line performance, optimizing working capital and enhancing shareholder value. This position will provide useful insights to help make better decisions about formulating and executing strategy. The CFO will interact effectively with all parts of the company and be viewed as a trusted business advisor. Critical outcomes include supporting the executive team with key financial information and operational data and analytics, and driving a culture of accountability in managing the business. The CFO will lead all financial administration, establish and monitor internal controls, business planning, pricing, budgeting and IT on a global platform. The position has the broad responsibility to understand and appreciate the ongoing importance of strong and effective accounting, financial, operational and business controls and to continually evaluate the adequacy of the controls in place, and to strengthen the respective controls as necessary.

Further, the position has the responsibility to identify, establish and evaluate the key business drivers for success (“metrics”) of the business for the management of the Company in order to achieve continued growth in revenue, efficiency, cost management, sales trends, margin analysis and profitability.

Another fundamental responsibility of the position is to insure the monthly financial statements and information (operational as well as financial) reflect the results of operations and financial condition of the business and the reported results, as well as the balance sheet, are not subject to surprise adjustments.

The CFO will manage Controllers at multiple locations including the UK, Spain and China and have overall responsibility for the quality and effectiveness of the business controls at each of the foreign locations. The CFO will provide financial analysis, valuation proposals, including risk assessment of all business acquisitions.

Duties and Responsibilities

  • Partner with the President on all operational and strategic issues as they arise; provide strategic recommendations to the President based on financial analysis and projections, cost identification and allocation, and revenue/expense analysis.
  • Participate in the ongoing strategic planning process as an integral member of the executive team. Provide relevant and appropriate business analytics to the leadership team so they may effectively manage their areas of responsibility and be aligned with the financial management of the company.
  • Report financial results, business risks, budgets and business strategies effectively to the CEO of Colson Associates.

Financial and Operational Management

  • Responsible for staffing all financial and IT positions for domestic and international businesses.
  • Oversee the preparation and approval of all financial reporting materials and metrics; including budgets, Flash report due the second work day of the month along with the CFO’s monthly and annual letter included in the monthly 10 Day Package and the annual financial statements. These reports will be submitted to Colson Associates.
  • Manage cash flow and forecasting; direct all financial, project-based, and departmental accounting.
  • Ensure the finance staff maintains financial record systems in accordance with Generally Accepted Accounting Principles.
  • Coordinate all audit activities.
  • Oversee business analytics and data management across multiple business functions including Sales and Marketing, using explanatory and predictive modeling and other analytical tools to drive fact-based decision making and manage business performance.
  • Collaborate with Sales and Product Management leadership to establish and implement Acumed’s pricing policy including policy components which allow for the review, approval and adjustment of strategic pricing based on industry/market landscape.
  • Review all formal Finance and IT-related procedures, processes, and administration, recommending improvements to the systems in place and managing the systems going forward with an objective of creating a competitive advantage for the company.
  • Develop and monitor all global internal control procedures to ensure uniformity and conformity with Colson Associates Policy Manual.
  • Develop and manage direct staff to include managers in finance and IT on a global platform, guide larger multi-discipline teams outside of direct span of control in the areas of contracts, acquisitions, royalties, capital improvements, and sales and marketing strategies.
  • Facilitate cross-department collaboration that ensures all financial and IT solutions positively support Acumed’s evolving strategy, operational delivery, and data collection needs.
  • Work closely with appropriate executive team member to insure through periodic rigorous testing and other means as necessary that robust and effective company compliance programs are in place and that the company compliance programs (such as, but not limited to, compliance with the Federal Food and Drug Administration, Foreign Corrupt Practices Act, Aggregate Spend/Sunshine Act, Affordable Care Act) are working effectively.

Qualifications

The CFO will have at least 15-20 years of broad finance and business leadership experience, ideally beginning with meaningful audit experience with a nationally recognized public accounting firm, followed by experience gathering and evaluating financial information and making actionable recommendations to senior leadership in a manufacturing and engineering environment serving a global market. The ideal candidate will have strong business acumen along with operations experience.

The CFO will have the following experience and attributes:

  • A minimum of a BS and CPA/CMA; an MBA would be a plus.
  • Proactive, and professionally mature with evidence of having worked as a true business partner to the President of a global business.
  • Demonstrated excellence in managing finance, accounting, budgeting, control, pricing, business analytics and reporting.
  • Skill in examining, developing, reengineering, and recommending financial and technology policies and procedures.
  • Strong analytical skills and experience interpreting a strategic vision into an operational model.
  • A collaborative and flexible style, with a strong service mentality. Needs to be seen as a team player who is committed to lifelong learning.
  • A hands-on leader with integrity and a desire for work in a dynamic, mission-driven environment.
  • An effective communicator, with strong verbal and written skills.
  • Bright and astute with good business sense and good common sense with a healthy business skepticism.
  • Strong commitment to developing team members.
  • Demonstrated experience in the identification and development of metrics and measurements to successfully manage, control and profitably grow businesses.
  • Demonstrated experience in the evaluation of business controls (identification of control weaknesses) and in the implementation of control improvements together with the development of methods to efficiently monitor controls compliance on an ongoing basis.
  • Demonstrated experience in effectively and efficiently managing components of working capital.
  • Demonstrated experience in providing oversight and aggressive management of operating expenses.
  • Successful in-depth experience with business enterprise systems
  • Demonstrated evidence of having experience in continually identifying, assessing and communicating risks and exposures within, or faced by the business and having developed measures to effectively mitigate such risks on a timely basis.
  • Demonstrated experience in the continual review and updating of product costing information and insuring that the product costs reflect actual cost and understanding the importance of communicating to the management team customer and product profitability trends and information.

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Finisher (Temp-to-Hire) OR, USA Operations Aug. 18, 2014

Under general supervision, the finisher finishes products according to approved prints through means of tumbling, deburring, polishing and/or blasting processes.

General Duties/Responsibilities
• Maintain Acumed's high quality standards. Know, understand, and follow all SOP's and WI's.
• Continual focus on customer service (Quality, Cost & Delivery), lean manufacturing concepts, and process improvement activities.
• Accurately and thoroughly complete appropriate paperwork, and computer transactions with minimal supervision.
• Conduct preventive maintenance on finishing equipment with general supervision.
• Assist with monitoring supply levels – inform appropriate personnel when supplies are low.
• Complete individual finishing projects (tumbling, deburring, polishing and blasting).
• Be proactive and promote a safe working environment. Keep work area clean and organized.
• Cross-train, coach and mentor cell members as assigned.
• Other job-related duties as assigned.

Qualifications
• High School Diploma/GED or equivalent.
• Experience in metal finishing (hand and machine) and media blasting preferred but not required.
• Experience with machine operation preferred but not required.
• Basic mechanical aptitude, good hand-eye coordination, and detail-oriented.
• Ability to read and understand blueprints. Basic math skills.
• Self-motivated and able to work with minimal supervision, work independently or in a team environment.
• Prompt and regular attendance.
• Reliable, dependable and honest.

 

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Sales Trainer OR, USA Medical Education Sep. 01, 2014

Job Purpose/Scope
The Sales Trainer conducts a wide range of training engagements including on-site and in-field sales training courses. Sales training courses will incorporate classroom, live video, and taped webinar sales support detailing effective sales techniques focused on Acumed’s strategic sales initiatives. Additionally, the Sales Trainer will provide the field sales organization learning outcomes driven by integrating sales methodologies, increasing market penetration, developing selling acumen, competitive insights, and product sales advantages to create confidence and excitement in choosing Acumed orthopaedic solutions. This position will support the Medical Education and Training Team Manager in the creation and execution of sales training and development plan.

General Duties/Responsibilities

  • Creates and delivers sales training content to the Acumed field sales organization focused on increasing product placement and selling skills.
  • Regularly assesses the sale force training needs by observing individual account manager’s performance/ behaviors and collaborates with the Medical Education and Training leadership to mitigate these needs.
  • Participates in strategic projects designed to fulfill the needs of the field Sales Force. These projects include continuous collaboration with all relevant support departments: Marketing, Regulatory, Product Management, Sales and include but are not limited to new product launches, new marketing directives, new indication launches and new positioning directives.
  • Analyzes and assesses sales training effectiveness to determine when revisions, enhancements, or new programs should occur and receives recommendation/input from team. Provides input to Medical Education and Training leadership.
  • Reviews department reports, sales trainee evaluations to evaluate the effectiveness of training feedback. Initiates continuous improvement plan based in response to this feedback.
  • Develops evaluations to measure training effectiveness and provide metrics for management review.
  • Acts as main point of contact for day to day operations related to development of new training initiatives or supporting changes in direction.
  • Oversee and manage on-site cadaveric lab usage. Implement business plan for leveraging the cad lab’s strategic future in sales training and other sales interests.

 

Qualifications

  • Minimum BS/BA/RN degree
  • 5+ years orthopaedic/healthcare commercial experience in sales, marketing, training, or related experience
  • 2+ years of orthopaedic training/teaching experience
  • Ability to develop/facilitate training classes/workshops
  • Excellent communication/presentation skills (both oral and written)
  • Demonstrated ability to work effectively both independently or in a team
  • Proficiency with Microsoft Office software (e.g. Power Point, Word, Excel)
  • Excellent planning and organization skills
  • Solid understanding of Acumed products and their surgical applications
  • Discretion, confidentiality and ability to build strong, trusting relationships
  • Solid understanding of global healthcare policies, trends and compliance issues
  • Conversational Spanish language skills, preferred

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Senior Regulatory Specialist Portland, OR USA Regulatory Sep. 18, 2014

Overview
The Senior Regulatory Specialist will function as the regulatory representative in the product development process to develop and execute product strategies. The Specialist will provide training and support for internal stakeholders, external customers, and the relevant compentent authorities. In additon, the Specialist will perform local country surveillance for assigned regulatory activities. Also, the Regulatory Specialist will ensure all records and systems supporting regulation are adequately maintaned and compliant to current regulations.


Duties/Responsibilities
• Must have a self-driven ability to investigate and understand regulations. Senior-level employee that works well independently and with a team, depending on the situation requirements.
• Initiate and maintain required establishment listings for FDA, EU MDD and CMDCAS including renewal or changes
• Initiate and maintain accurate international product registration, including renewal or changes, and certificates for foreign governments
• Manage correspondence with the regulatory and standards agencies or organizations such as FDA, MDD Notified Body, Health Canada, ISO, Acumed's EU Authorized Representative
• Prepare, organize, coordinate content/data and ensure regulatory compliance for submission to the FDA or regulatory agencies (e.g. 510(k), PMA, MDD Technical Files/Design Dossiers, global registration applications, etc.)
• Ensure all processes for the essential functions are documented in procedures
• Review and disposition ECRs/ECOs for potential impact to new and existing registrations.
• Review of all Product labeling to assure compliance with registrations.
• Assist in determination of appropriate product testing to support registration activities.
• Determine the best strategy to register new products in specific global markets


Qualifications
• Masters of Science in Regulatory Affairs, Biology, Chemistry, Engineering or related field required and 5+ years direct experience or Bachelor's degree and 7+ years of experience
• Evidence of applied knowledge of applicable FDA, CMDCAS, ISO, MDD, region-specific requirements and consensus standards
• Ability to work with FDA, Notified Body, EU Authorized Representative and other global regulatory agencies
• Able to manage multiple projects simultaneously
• Proven track record of strong team work, creatively strategic thinking
• Ability to work well with others, support regulatory activities and mentor/train others
• Excellent written and verbal communication skills

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Accounting Specialist (Temporary) Portland, OR, USA Accounting - AP Sep. 18, 2014

Overview
The Accounting Specialist is responsible for a variety of different responsibilities, which may include the areas of Accounts Receivable, Accounts Payable and General Accounting. The Accounting Specialist utilizes current systems to complete transactions, research and resolve discrepancies in transactions, maintain reports and provide effective communication to internal and external customers.


Essential Duties/Responsibilities
• Create new vendors in SAP
• Create Purchase Orders in SAP
• Create Internal Orders in SAP
• Voucher invoices received from vendors and check requests received internally
• Bank & petty cash reconciliations
• Accounts Payable accrual (freight, temp labor, utilities, open & no purchase orders)
• Generate payments (including wire transfers) against vouchers
• Transmit payment information to support positive pay procedures
• Work with Receiving and Planning to improve processes and reduce errors
• Review PO Accrual report on a regular basis and make adjustments as necessary
• Create Purchase Orders in SAP
• Create Internal Orders in SAP
• Process annual 1099 forms


Qualifications
• College coursework in accounting or business administration or equivalent experience preferred.
• 1+ years experience working in an accounting environment preferred
• Knowledge of basic accounting concepts, practices and procedures
• Strong organizational skills in order to prioritize and complete work efficiently
• Ability to independently conduct research on discrepancies with transactions
• Excellent verbal and written communication skills in English, including the ability to interact with all levels of personnel
• Flexibility to adapt to changing priorities
• Attention to detail with an eye for accuracy

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.