Principle Regulatory Affairs Specialist

Location: Minneapolis, Minnesota, United States
Salary: Negotiable
Job Type: Contract
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Are you a Regulatory Affairs Specialist with extensive experience in the Medical Device Industry? Looking for your next opportunity with the ability to work fully remotely? Look no further! My client is currently picking up multiple regulatory projects and is now hiring for a Principal Regulatory Affairs Specialist. This role will be structured as a 6-12 months contract-to-hire.

The Regulatory Affairs Specialist will be expected to take on an immediate leadership role, coordinating, writing, reviewing, and submitting regulatory submissions such as IDEs, 510k, Technical Files, Design Dossiers, etc.

Among others, the Regulatory Affairs Specialist will have the following responsibilities:

  • Performing gap assessments to EU MDR for Medical Device Class ll and lll
  • Provide remediation guidance for clients, ideally project related to transition from MDD to MDR
  • Ensure adherence to project budgets, time schedules, and scope of work
  • Effectively manage time to support multiple projects and cross-functional projects
  • Participate in planning and execution to clients' strategic regulatory development

The most desirable candidates will possess the following qualifications:

  • 8+ years of Regulatory Affairs experience in the Medical Device Industry
  • Expertise with current regulatory agency guidance and regulation such as EU MDR, 510k, Technical Files, ISO 13485, ISO 14971, etc
  • Experience/Working Knowledge of regulatory submission in various countries such as Canada, China, Europe, Australia, etc.

Overall, this is a wonderful opportunity to join a company with exciting projects while having the ability to work remotely.

If you are interested in learning more about this opportunity, please forward your resume and/or contact me on the details below!

Sthree US is acting as an Employment Business in relation to this vacancy.

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