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Regulatory Affairs Specialist

Bothell, WA

Job Type: Contract
Job Id : 309504
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Position Summary

We have an excellent opportunity with a leading client for a Regulatory Affairs Specialist. In this role, you will support the international export of medical devices.

This position has a great benefit package that includes Medical, Dental and Vision benefits, 401k with company matching, and life insurance for those who qualify.

Responsibilities of the Regulatory Affairs Specialist:

  • Prepare U.S. Regulatory submissions for new products and product changes to ensure timely market clearance
  • Review product changes for compliance with applicable regulations, support business segment product lines, special projects and strategic initiatives
  • Prepare technical files to include Notices of Change for CE Marking of medical devices

Requirements of the Regulatory Affairs Specialist:

  • Strong experience in regulatory affairs for the medical device industry
  • Experience with PMAs (Pre-Market Approvals)  
  • Experience evaluating engineering changes
  • Experience with Pre-Subs (Q-sub)
  • Experience with Electro-Mechanical Devices strongly desired
Keywords: Regulatory Affairs Specialist, International Export, Medical Devices, PMA, Pre-Market Approvals, Pre-Subs, Q-Sub, Electro-Mechanical Devices

Job ID: 309504

About Eliassen Group:

Eliassen Group provides strategic talent solutions to drive our clients’ innovation and business results. Leveraging nearly 30 years of success, our expertise in IT staffing, Agile consulting, creative services, managed services, and life sciences enables us to partner with our clients to execute their business strategy and scale effectively. Headquartered in Reading, MA and with offices from coast to coast, Eliassen Group offers local community presence, deep networks, as well as national reach. For more information, visit

Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Don’t miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!

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