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Acumed provides a progressive and exciting workplace. In an industry with double-digit growth, our growth has consistently outpaced the competition. Acumed's position as an innovator in the orthopaedic implant market means that we move quickly to take advantage of areas unaddressed by larger companies. This creates a dynamic environment in which employees are supported in growth and responsibility. Our people are by far the most valuable resource we have.
We believe strongly in empowering each one to make a difference in the future of the company and the lives of the patients who receive our implants. Pushing the limits in orthopaedics takes us all to new heights whether that is in engineering, production, inspection or marketing.
We encourage health and happiness at Acumed, and we devote a large amount of resources to ensure it. We provide benefits that enhance health, allow planning for the future, and promote general well-being.
Acumed is proud to offer employees a comprehensive benefit package, including:
- Generous PTO
- Medical, Dental and Life Insurance
- Short and Long Term Disability Insurance
- 401(k)
- Nine Paid Holidays
- Retirement Plan
- Flexible Spending Accounts
- Employee Assistance Program
- Educational Assistance
- TriMet Bus Passes
- Reduced Costco Memberships fees
- Reduced Gym Memberships fees
- Credit Union Membership
- An employee referral program
- Bike room and showers
Acumed is currently hiring for a variety of positions within our organization. To apply for an open position, Submit resume, with salary history and cover letter to: resumes@acumed.net
Resumes without cover letter and salary history will not be considered. No phone calls please.
Regulatory Specialist 2
This position assists the Regulatory Supervisor in creation, development and maintaining materials needed for regulatory compliance and is responsible for assisting with company compliance activities, new product submissions, listings, and registration of medical devices. This candidate will work under minimal supervision of Regulatory Supervisor. A self-driven ability to investigate and understand regulations is required for moderate to highly complex assignments. Employee works independently as necessary.
To apply, submit your resume, cover letter and salary requirements to: https://home.eease.com/recruit/?id=490655
**Resumes without salary information will not be considered
Duties/Responsibilities
-Initiate and maintain required establishment listings for FDA, EU MDD and CMDCAS including renewal or changes
-International product registration, including certificates for foreign governments including renewal or changes
-Manage correspondence with the regulatory and standards agencies or organizations such as FDA, MDD Notified Body, Health Canada, ISO, and EU authorized representative.
-Prepare, organize, and coordinate data for submission to the FDA or regulatory agencies: i.e. 510(k), PMA, MDD Technical Files
-Participate in the preparation and execution of ISO and FDA audits
-Assist in determination of appropriate safety, regulatory, evaluation and testing requirements for new and approved products.
-Product development team contributor, provide regulatory/compliance perspective and expertise, to assure products are in compliance with relevant US and foreign standards and codes.
Qualifications
-Bachelor of Science in Biology, Chemistry or related field required
-Thorough working knowledge of applicable FDA, CMDCAS, ISO, and MDD requirements and consensus standards
-3+ years of regulatory/quality project management experience
-5 – 7 years of experience in the medical device or equivalent industry (quality, regulatory field, or orthopedic engineering)
Excellent benefits, including medical, dental, life, 401(K), Vacation, PTO and Flex Spending. No phone calls please. EEO, Drug Free Environment.
