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Regulatory Affairs Manager

Real Staffing Andover Full-Time
$120,000.00 - $130,000.00 / year
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Recruiting for a Global Medical Device company in the greater Minneapolis area, who is seeking a Regulatory Affairs Manager. You will be working on electro-mechanical medical devices. These are exciting products, it involves working on advanced catheter systems, guidewires, medical balloons, extrusions, and laser micro-machines and welded assemblies and are a single source of manufacturing expertise for advanced medical devices.

Responsibilities:

  • Manage a team of regulatory affairs Specialists
  • 510K Authorship and management of submission process
  • Work closely with the R&D development team to provide regulatory input and guidance.
  • Responsible for development of labelling.
  • Management of MDSAP audit

Qualifications:

  • Bachelor's degree
  • 8 years of Regulatory Affairs experience in the medical device industry
  • Strong leadership skills, and ability to work effectively within a team
  • Previously authored 510K

Salary is depending on experience, range up to $130K & 6% BONUS

Please apply or call Francesca White if you are interested, and Real Staffing with reach out to discuss this opportunity. 312-453-9077

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

 

Skills required

Regulatory Legislation And Guidelines
Innovation
Research
Operations
Leadership
Technical Services
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Job ID: RE-33198986

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Real is a global leader in the provision of pharmaceutical, biotechnology and medical devices recruitment services. We are one of the world’s most extensive pharma, biotech and medical devices recruiters and have one of the largest networks of specialist recruiters globally.

Our premise is a simple one: by recognizing talent and valuing relationships we are able to consistently deliver local, global and industry expertise which in turn ensures success time after time.

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