Role details

Regulatory Affairs Manager - OEM Medical Device - Mass.

Minneapolis   •   USD110,000 - USD135,000   •  Permanent

Bullet points

  • OEM Medical device company - Relocation to Marlborough, MA
  • 510k submissions experience; hands on and strategic role

About Our Client

Michael Page is partnering with an OEM Medical device company west of Boston. Though already well established with sites around the world, they have strong growth projections over the next few years. This company manufactures and sells multiple product lines that typically have an electronic or surgical application, and are continuing to bring new products out to market every year.

*Relocation to MA provided as position is located in Marlborough, MA

Job Description

The Regulatory Affairs Manager - OEM Medical Device will be responsible for:

  • Assist in guiding the organization with Regulatory Affairs strategy and vision
  • Ensure regulatory compliance issues are properly managed through the ISO 13485 Quality systems and are reported appropriately
  • Serve as the local Regulatory leader for the internal and external audits
  • Manage FDA Establishment registration and listing as applicable
  • Provide leadership and guidance for 510k submissions
  • Make recommendations for staff and equipment and have significant input into personnel matters

The Successful Applicant

The Regulatory Affairs Manager - OEM Medical Device will have:

  • BS Required; BS in Engineering preferred
  • 7+ years of regulatory affairs experience within medical device
  • ISO 13485
  • Effectively lead Regulatory strategies and vision
  • 510k submissions

What's on Offer

  • Great team culture
  • Growing organization
  • Competitive compensation package
  • Work/life balance

Apply for this job

Click the Apply or LinkedIn button below or contact Morgan Bernstein quoting job reference 1216438
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