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Principal Regulatory Affairs Specialist

Employer
JJ SONIK
Location
Minneapolis
Salary
Competitive

View more

At JJ Sonik, we bring individuals and companies together with a specialization in relocation.


Top three reasons to consider relocation:


?? You can always come back home. Today, companies don't expect you to retire from the Organization. Commit to a time frame, 3-5 years often represents a return of investment for both parties. Evaluate at that time.


?? Positions that require relocation commonly pay higher than positions that can hire from a local candidate pool. You can take that compensation level with you for your entire career. That can have a lifetime impact of hundreds of thousands of dollars.


?? It isn't really that dramatic or complicated. We are masters at making the transition seamless.


So, if you or someone you know has the following experience and is open to the possibility of an opportunity away from Minneapolis, please reply in confidence.


We'll tell you all about the position including it's location. Give us an opportunity to tell you what we like about it.


Qualifications & Responsibilities for the Principal Regulatory Affairs Specialist


  • Preparing comprehensive global regulatory strategies for new devices and manufacturing processes.
  • Clearly communicating strategies to RA management, core teams, and business unit leadership
  • Preparing global regulatory filings for new products, as well as product and manufacturing changes. Domestic Class II 510(k)'s preferred. Class III PMA nice to have.
  • Knowledge and experience in MDR, MDD, and MDSAP
  • BS degree in a relevant field (BS/MS in engineering or science preferred)
  • 5+ years of Regulatory Affairs medical device experience with BS degree, and work experience in Regulatory, R&D, Quality, Clinical or Manufacturing
  • Considered a key regulatory point person in a scientific or technical discipline, e.g. biocompatibility, mechanical testing, preclinical testing, risk management, CMC etc.
  • Can be trusted by Regulatory Affairs (RA)management as an independent regulatory core team lead on project teams

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