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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 pass subsidy
  • Costco membership subsidy
  • Gym membership subsidy
  • An employee referral program
  • Bike room and showers

Current Open Positions

Position Location Department Posted Onsort descending
Quality Manager, Acute Innovations Hillsboro, OR, USA Acute Mar. 05, 2015

The Quality Manager for Acute Innovations is responsible for directing Quality Assurance activities to support all aspects of Quality programs. They build successful teams, develop and lead people to achieve continuous improvement and drive change throughout the organization.

Acute Innovations is a subsidiary of Acumed.

Duties/Responsibilities
-Management representative for the quality system, which maintains compliance to FDA/QSR requirements.
-Oversee quality and inspection operations.
-Coordinate the inspection and quality duties throughout company.
-Assure ongoing compliance to the Quality Assurance Manual.
-Support and participate in the quality objectives within the company.
-Supervise Quality personnel.
-Qualifies and monitors vendors.
-Reviews, approves, verifies, and participates in Corrective Action.

Qualifications/Requirements
-B.S. in Engineering or related field
-Thorough knowledge and experience in FDA, CMDCAS, ISO, and MDD
requirements and consensus standards.
-5+ years of quality assurance experience preferred
-Experience in the medical device or equivalent industry (quality or
medical device engineering)

To apply, please visit our applicant registration page

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

International Marketing Manager Hillsboro, OR, USA Marketing Apr. 08, 2015

The Marketing Manager supports the achievement of revenue goals by developing strategies and programs to increase the adoption of on-market products and to optimize the launch of new products in partnership with Product Management. In order to ensure that the strategies and programs developed will be effective, the Marketing Manager conducts market research to understand targeted customer groups, industry trends and competitive strategies. By providing oversight over how Acumed's product marketing initiatives come together, the Marketing Manager will also work closely with the Marketing Communications team to ensure that all advertisements, PR, on-line promotional strategies, etc. align with the annual regional marketing plan.


Duties/Responsibilities
• The Marketing Manager aligns individual product marketing plans generated by Product Management to develop a marketing plan for their assigned region.
• Implements annual regional marketing plan and budget that effectively supports the sales organization achieve its annual revenue goal.
• Ensures marketing communications are coordinated, support marketing plan objectives and meet organizational expenditure requirements.
• Conducts primary and secondary market research to drive improved customer insights and understanding of industry trends, compiles and analyzes data for use by product management and sales. Refines marketing plan based on data analysis.
• Assesses competitive strengths and weaknesses and consolidates the data for use by product management.
• Using market research, helps define target customer and develops programs and tools that will facilitate the acquisition of new customers and the retention of current customers.
• Using market research, helps define and communicate Acumed vs competitive positioning to ensure market competitiveness. 
• Supports new product launch priorities working with RBMs to define each product's Distribution Plan. 
• Maintains relations with agents through frequent communication that helps us better understand their needs and how we can increase their focus on selling Acumed products.


Qualifications
• BA/BS in Business or related field required; Master's in Business Administration preferred.
• Minimum of 3 years of experience in marketing; at least 2 years of experience with medical products or medical devices highly preferred.
• Orthopaedic, trauma, dental, or spine experience highly preferred.
• Knowledge of business development principles related to strategic planning and resource allocation.
• Demonstrated track record of success in developing marketing plans and managing marketing processes.
• Demonstrated strategy, communication, and presentation skills.

To apply, please visit our applicant registration page

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

Instructional Designer Hillsboro, OR, USA Medical Education Apr. 10, 2015

The Instructional Designer develops and designs curriculum and content for Medical Education and Sales Training programs for Acumed personnel and customers to promote the safe use of our products, increase product knowledge, and sales techniques. This position combines in-depth knowledge of adult learning theory and skill development, various forms of instructional media, and facilitation expertise. The Instructional Designer develops an entire curriculum from individual courses to entire programs, with multiple coursework. Keeps abreast of emerging instructional design theory, instructional technologies, and developments in technology enhanced learning tools by participating in professional development and research activities.

Duties/Responsibilities
• Develop training objectives roadmap for overall curriculum structures and develop education plans for each project. Design and implement the process for curriculum planning and course development.
• Develop project proposals including budgets, timelines as part of curriculum development process.
• Design, develop and implement e-learning and classroom training for various target audiences using appropriate writing styles to make content easy to understand. 
• Create online self-paced training modules that reinforce key anatomy, procedure, and product objectives.
• Analyze learning aims and objectives and work with Subject Matter Experts (SMEs) to design solutions that align with learner and business needs. Apply instructional design theories and practice.
• Develop training on competitive product initiatives to ensure field salesforce can respond to competitive product offerings.

Qualifications
• Bachelor's degree in Education, Clinical (R.N. RPh) or Technical area such as engineering or science required. MS in Instructional Design & Development or Education preferred
• 3 or more years of experience developing educational content at the corporate level
• Prior curriculum design experience required; Instructional Design & Development or Education preferred.

To apply, please visit our applicant registration page

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

Process Engineer Hillsboro, OR, USA Process Engineering Apr. 22, 2015

The Process Engineer (PE) supports Wet Processing production cells and new product development teams to meet operational objectives by developing, integrating, and improving production processes and systems. The Process Engineer also ensures compliance to Acumed, FDA, and ISO regulations.

Duties/Responsibilities
• Develop and implement advanced production fixtures
• Develop new production Routes, Bill of Materials (BOMs), and Inspection Plans via ECOs
• Manage Quality Notification (QN) system and disposition all non-conforming product
• Support corrective/preventative action activities (CAR/SCAR)
• Prepare and analyze quality metrics to identify repeated quality issues
• Lead cell level Process Improvement (PI) initiatives and implement Lean tools
• Develop manufacturing plans and timelines for new product release
• Review new product design for manufacturability prior to production release
• Coordinate Pilot Production Runs and conduct production readiness reviews (PRR)
• Develop and execute Process Validation protocols and reports
• Implement and improve upon existing manufacturing processes

Qualifications
• 2-6 years process engineering or related experience
• Applied 3D CAD experience in Autodesk Inventor, Solidworks, PRO-E or equivalent
• Applied understanding of Geometric Dimensioning & Tolerancing (GD&T)
• Applied understanding of Process Validation (IQ, OQ, & PQ) requirements
• Wet Processing experience desired
• Experience in the Medical Device industry desired
• Knowledge of FDA and ISO 13485 Regulations
• Understanding of Risk Management and experience with tools such as FMEA

To apply, please visit our applicant registration page

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

Finisher (Day Shift) Hillsboro, OR, USA Production Jun. 23, 2015

The Finisher finishes products according to approved prints through means of tumbling, deburring, polishing and/or blasting processes. This is a great opportunity to expand your manufacturing skillset!

This position is on a day shift schedule (M-Th 5:00am - 3:30pm).

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).

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.

To apply, please visit our applicant registration page

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

Quality Assurance Technician Hillsboro, OR, USA Production Jun. 23, 2015

The Quality Assurance Technician inspects material, products, or processes, purchased or manufactured, to the required drawing or print specification, or other controlling document.

This position is assigned to a mid-day shift.


Duties/Responsibilities
• Perform first article dimensional and documentation inspections.
• Audit In-process records, receiving inspection documentation, final inspection documentation, and other quality or manufacturing data for accuracy and completeness.
• Evaluate inspection processes for improvement using standard problem solving and improvement techniques (i.e. Redundant inspections, improved techniques and instructions).
• Actively participate in Manufacturing Cell teams as a Quality representative by addressing quality-related issues per documented processes.
• Accurately enter information into manufacturing data gathering system.
• Maintain and update Quality system documentation, such as work instructions, procedures, in-process inspection information, and other related documentation.
• Address and follow-up on quality-related issues between departments (i.e. Manufacturing Engineers, Design, Quality Engineers, Planning, Manufacturing).
• Demonstrate an understanding of final acceptance activities.
• Create Non-Conforming Material Reports (NCMR's) as needed.
• Participate in MRB (Dispositions – NCMR).
• Maintain calibration of gages and integrity of calibration system by accurately entering information.
• Track the status of receiving inspections (FIFO, Visual Indicators).


Qualifications
• High School Diploma/GED or equivalent
• Two years manufacturing experience required; 1 or more years of experience in manufacturing inspection preferred.
• Ability to read and speak English sufficiently to read work instructions, specifications and procedures and complete all paperwork.
• Ability to use precision measuring equipment including micrometers, calipers, gage pins, optical comparators, and other inspection equipment.
• Ability to read and understand engineering drawings and specifications related to manufactured products.

To apply, please visit our applicant registration page

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

Finisher (Swing Shift) Hillsboro, OR, USA Production Jun. 25, 2015

The Finisher finishes products according to approved prints through means of tumbling, deburring, polishing and/or blasting processes. This is a great opportunity to expand your manufacturing skillset!

This position is on a swing shift schedule (M-Th 3:00pm - 1:30am).

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).

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.

To apply, please visit our applicant registration page

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

Senior Graphic Designer Hillsboro, OR, USA MarCom Jun. 26, 2015

The Senior Graphic Designer combines graphic design and marketing to create marketing materials that represent the Acumed brand. The Senior Graphic Designer leads the design process and participates in strategy development for promotional materials to support events, trainings, product launches and corporate promotional campaigns.


Duties/Responsibilities
• Designs complex or difficult projects using expertise and knowledge to graphic design principles.
• Serves as the lead designer to turn visualizations into comprehensive designs that extend brand messaging across multiple media channels to deliver effective marketing materials within budget guidelines.
• Maintain and promote the Acumed Global Brand/Identity Guide.
• Manage project workload for quality and adherence to deadlines. 
• Work with US and International Marketing Managers to understand market segments and develop marketing promotions to target them.
• Collaborates effectively to evaluate, identify and recommend opportunities to strengthen the Acumed brand and amplify customer brand experience.
• Develops and produces creative brand designs to ensure imagery and messaging promotes Acumed's brand identity.

Qualifications
• BS/BA in Graphic Design or related field required 
• 4 years or more experience in graphic design
• Manage multiple priorities, be detailed focused, and highly organized

To apply, please visit our applicant registration page

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

Product Manager, Acute Innovations Hillsboro, OR, USA Acute Product Management Jul. 08, 2015
ACUTE Innovations, a subsidiary of Acumed, is looking for an energetic Product Manager to help our business continue to grow! ACUTE offers an innovative product portfolio, a robust benefits package, and a strong employee culture.

The Product Manager plans, organizes, and controls an assigned ACUTE Innovations Product Segment/family from conceptual stages through product life cycles to optimize profit and meet marketing, financial and corporate growth objectives.

Duties/Responsibilities
• Assists in developing strategies to adjust and promote various product lines, to improve sales and profit.
• Develops and manages action plan(s) for new product introduction.
• Oversees the formulation of marketing strategies and tactical execution including pricing, selection or market segments for special emphasis, promotional and advertising support of sales, and specifying the necessary product characteristics.
• Works closely with internal and external resources to determine business unit needs for growth.
• Directs medical education courses including setting the faculty, initiating the topics to be covered, and working with surgeons in presentations to help promote ACUTE Innovations product.
• Develops relationships with key surgeon consultants to drive product sales.
• Participates in conventions and professional exhibitions to maintain company image and remain aware of product requirements and new market opportunities.
• Prepares long range, annual, quarterly, and monthly forecasts for each product line. Analyzes forecasts variances and recommends corrective actions to minimize future back orders or potential obsolescence. Reviews forecast for product requirements and originates plans and objectives to continually be competitive with or ahead of market needs.
• Develops and maintains product line technical expertise and contacts with key surgeons and customers of product responsibility by observing surgery, attending medical/scientific meetings, presentations, and seminars while gathering competitive information.
• Determine list pricing for all assigned products via thorough competitive analysis, market trends, etc.
• Conducts market research activities to analyze and identify market needs and issues. Evaluates existing ACUTE Innovations product lines in light of those changes and develops line simplification strategies when appropriate.
• Trains and assists ACUTE Innovations field representatives on products and competition.

Qualifications
• BA/BS in marketing, communications or related field.
• At least 5+ years of experience in a sales or classical marketing function, preferably with direct product management experience
• Background in orthopedic products or medical devices highly preferred
• Strong interpersonal and relationship management skills
 

To apply, please visit our applicant registration page

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

Quality Systems Specialist Hillsboro, OR, USA Quality Jul. 16, 2015

The Quality Systems Specialist (QSS) uses independent judgment to design, implement, and manage the Corrective and Preventive Action Program (CAPA), the Internal Quality Audit System, and Field Actions Program related to implicated product.  The QSS implements and maintains the Acumed quality system in compliance with applicable regulations.  Research and implement current regulations to ensure multiple interdependent systems (CAPA, Quality Audit, and Field Actions Program) are updated and compliant with current requirements.  The QSS drives integration of various quality systems to ensure continuous compliance with global quality system requirements and ensures the processes supporting the quality system are robust and support the evolving requirements of Acumed's product line.

Duties/Responsibilities
• Owns and executes all aspects of CAPA program administration ensuring compliance with the quality standard. CAPA program administration includes authoring, updating, and driving compliance with standard operating procedures (SOPs), work instructions (WIs), and forms. 
• Respond to CAPA requests and open new CAPAs when appropriate.
• Verify CAPAs are thoroughly investigated and accurately documented in the system.
• Review all CAPAs prior to closure to assure all required actions were completed; perform effectiveness checks at established intervals in a timely manner.
• Partner with senior leadership to ensure CAPAs are appropriately resourced for closure within a reasonable timeframe.
• Own and execute all aspects of Acumed's Internal Quality Audit system administration ensuring compliance with the quality standard. Internal Audit system administration includes authoring, updating, and driving compliance with standard operating procedures (SOPs), work instructions (WIs), and forms. 
• In collaboration with the Quality Manager, create, distribute, and maintain the annual internal audit schedule.
• Coordinate with leaders in other departments to ensure sufficient auditing resources are available to support the audit schedule.
• Mentor and develop Acumed employees in other departments as internal auditors; coordinate required external certification to qualify internal auditors.
• Ensure audits are completed on schedule, results are communicated to the appropriate people, and the internal audit findings are promptly closed by collaboration with responsible department leaders.
• Support the Quality Manager during third party (i.e. Notified Body, FDA, Health Canada, ANVISA) assessments of Acumed's quality system.
• Assess, report, and implement new and changing regulations or the addition of new markets to the quality system.
• Execute Field Action activities by coordinating and facilitating the removal of implicated product from the field.
• Manage the creation and approval of Health Hazard Evaluations (HHEs) ensuring input and agreement from stakeholders
• Analyze HHEs in preparation for management review.
• Create, maintain, and disseminate reports and metrics on CAPA system activities, Internal Quality Audit system, and Field Actions for management.


Qualifications
• Bachelor's degree in an engineering or science discipline required; advanced degree preferred
• 5-10 years of experience in a quality role in medical device manufacturing.
• Working knowledge of applicable Code of Federal Regulations and ISO 13485.
• Extensive knowledge of Quality System Regulation, US FDA, and ISO 13485. Experience with international quality system regulations preferred.

 

To apply, please visit our applicant registration page

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

Packager Hillsboro, OR, USA Special Processes Jul. 20, 2015

The Packager performs manual packaging operations or sets up and operates machinery to pack and/or wrap containers with finished product for storage or shipment.

This is a great opportunity with a growing manufacturing department. This position is eligible for a robust medical benefits package, annual discretionary bonus opportunity, 401(k) plan, and much more!


Duties/Responsibilities
• Package all non-sterile product for storage in inventory
• Identify product according to label and insert appropriate documentation
• Consistently and accurately inspect, verify, and reconcile orders and labels
• Observe operations and inspect packaged items for conformance with specifications
• Identify equipment malfunctions and report needed repairs
• Maintain accurate inventory of packaging materials


Qualifications
• High school diploma or equivalent combination of education and experience
• Ability to communicate effectively with coworkers and supervisor
• Ability to read and speak English sufficiently to read, understand and complete all paperwork.

To apply, please visit our applicant registration page

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

Human Resources Assistant Hillsboro, OR, USA Human Resources Jul. 28, 2015

Acumed is looking for an HR Assistant to join our team! This position is a key contributor to multiple functions of HR, including recruitment and selection, employee benefits, HRIS administration, and performance management. The HR Assistant also provides routine coverage of the reception desk.


Duties/Responsibilities
• Receive and record employee performance appraisals in the HR Information System, file upon completion of processing
• Receive and file personnel related documentation, including staffing, recruitment, training, performance evaluations, and employee leaves of absence; provide information for payroll and other uses as required
• Provide routine reception desk coverage
• Gather personnel records from other departments or employees
• Examine employee files to answer inquiries and provide information for personnel actions
• Assist with recruiting and on-boarding including scheduling interviews, checking references, processing background checks, arranging drug tests, and making new employee files
• Record, update, and maintain employee information in the HRIS system and employee files per established procedures
• Refer employees to appropriate resource to find Company policies, procedures, laws, standards and government regulations
• Maintain Company bulletin boards ensuring proper documents are posted and removed as required
• Assist planning of companywide events
• Prepare and create standard reports as assigned
• Maintain strict confidentiality


Qualifications
• Associates degree in Human Resources or business related field preferred; Bachelors degree preferred
• Two years related administrative work experience required, preferably in human resources
• Interpersonal and communication skills including the ability to communicate effectively with employees at all levels of the organization
• Knowledge of principles and processes for providing customer service to internal and external HR customers
• Basic knowledge of principles and procedures for human resources including Human Resource Information
• Systems, recruitment, selection, training, benefits, and compensation
• Ability to identify problems, review related information, develop and evaluation options, and implement solutions

To apply, please visit our applicant registration page

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

Regulatory Affairs Specialist I Hillsboro, OR, USA Regulatory Jul. 28, 2015

The Regulatory Specialist I helps create, develop and maintain materials needed for regulatory compliance. Assists with company compliance activities, new product submissions, listings, and registration of medical devices. This is a great opportunity for a junior Regulatory Affairs professional!

Duties/Responsibilities
• Understands regulations, follows complex directions, and investigates when clarification is needed.
• Initiates International product registration, including renewals or changes and certificates for foreign governments
• Manages correspondence with the regulatory and standards agencies or organizations such as FDA, MDD Notified Body, Health Canada, Medimark
• Prepares, organizes, and coordinates data for submission to the FDA or regulatory agencies (e.g. 510(k), MDD Technical Files, etc.)
• Participates in the preparation and execution of ISO and FDA audits
• Assures regulatory compliance and content accuracy of Technical Files and 510(k) files
• Completes the duties described in the Quality Manual
• Converts and/or approves ECRs/ECOs requiring regulatory review
• Assists in package insert (instructions for use) development, organization and application
• Assists in determination of appropriate safety, regulatory, evaluation and testing requirements for new and approved products
• Product development design review team and risk team contributor, providing regulatory/compliance perspective and expertise, to assure products are in compliance with relevant US and foreign standards, codes and regulations


Qualifications
• Bachelor of Science in Biology, Chemistry or related field required
• Knowledge of applicable FDA, CMDCAS, ISO, and MDD requirements and consensus standards
• 1 - 3+ years of regulatory experience
• Ability to support product development projects

To apply, please visit our applicant registration page

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

Quality Engineer III Hillsboro, OR, USA Quality Jul. 28, 2015

This position has the responsibility and authority to provide Quality Assurance Engineering representation to Product Development teams. This position owns the risk management profile for products during their entire lifecycle, including risk identification, completion, and management of risk mitigation activities. Participates in facilitation of initial product design, development, design transfer to manufacturing, and process improvements to obtain optimum product reliability, safety, and effectiveness. Coordinate feedback of quality indicators and statistics to organization for use in business decisions. Partner with Operations and Engineering in process improvements.


Duties/Responsibilities
• Provide quality leadership in product development teams to the entire design lifecycle of Acumed products to ensure compliance with Acumed policies and global regulations, including FDA Quality System Regulation and ISO 13485. The design lifecycle includes design control, design verification and validation, design transfer, process validation, risk management, and specification development.
• Coordinate with Regulatory staff members to ensure that product testing and design requirements for intended markets are identified, part of the product requirements as documented in the Design History File, and met during the product development. Represent the needs of the Regulatory team during product development.
• Guide teams to ensure robust application of appropriate design and manufacturing controls.
• Educate project teams on requirements related to regulations, procedures, and requirements. Provide training, guidance and interpretation.
• Ensure quality and completeness of project design history files, risk management files, validation packages, and change orders.
• Provide ongoing quality engineering support throughout the product life cycle, including risk management, design and manufacturing changes, and CAPA investigations.
• Lead all risk management activities for products throughout their lifecycle, including risk identification, completion, and management of risk mitigation activities.
• Be a strong representative for Quality and Regulatory concerns during technical discussions and risk-based decision making; ensure issues are resolved using a risk-based approach.
• Monitor the quality and performance of new products to ensure requirements are met and product is performing as anticipated. Identify concerns, develop a risk-based solution with impacted departments and lead implementation efforts, as appropriate.
• Drive the creation and approval of verification and validation reports and identify gaps for compliance with Acumed policies and global regulations. Develop and execute strategies to close gaps in an efficient, technical, and compliant manner.


Qualifications
• Bachelor's degree in an engineering or science discipline; advanced degree preferred
• 8-10 years of experience working in quality assurance role in a regulated environment. Experience working with implantable devices preferred.
• Experience applying quality regulations and standards (e.g. 21 CFR 820, ISO 13485, ISO 14971, Medical Device Directive, etc.)
• Experience with CAPA and failure investigation tools and techniques.
• Applied experience with quality and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, DOE, trend analysis, etc.)
• Knowledge of ERP Systems (SAP preferred) and advanced Microsoft Office; expert level Microsoft Excel skills.
• Certified Quality Engineer (or equivalent) preferred.

To apply, please visit our applicant registration page

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

Regulatory Affairs Specialist III Hillsboro, OR, USA Regulatory Jul. 28, 2015

The Regulatory Specialist III 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 competent authorities. In addition, 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 maintained 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
•  Bachelor's degree required in Regulatory Affairs, Biology, Chemistry, Engineering, or related field

• 3-5+ years of related experience required
• 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.