Role details

Medical Device Regulatory Affairs Specialist

Largo   •   USD70,000 - USD85,000   •  Permanent

Bullet points

  • Domestic Affairs/Legal Affairs/Compliance/Regulations/ 510k Submissions
  • Medical Device experience required

About Our Client

Our client is a leading OEM medical device company with locations throughout Europe and the US. With a wide array of medical device products mostly with electro-mechanical components, they have an open position to join a growing team in Largo, FL for a Regulatory Affairs Specialist with experience working on medical device submissions and domestic policies.

Job Description

The Regulatory Affairs Specialist - Medical Device will need experience with supporting the legal department in a wide range of matters, including litigation, compliance, and corporate transactions for all commercial/business claims with due diligence.

  • Maintain and facilitate renewal and cancellation of corporate contracts
  • Obtain/maintain market access for cutting edge products worldwide by working with cross functional teams and international regulatory bodies/distributors
  • Lead improvements to processes for continuous improvement strategies while communicating technical data throughout organization.
  • Assist on 510k submissions and other domestic regulatory affairs

The Successful Applicant

The Regulatory Affairs Specialist - Medical Device will have:

  • Bachelor's Degree
  • Minimum 3 year's experience in regulatory affairs
  • Experience working with medical devices
  • Experience with 510k submissions
  • Domestic policy experience
  • Excellent communication
  • Strong work ethic

What's on Offer

  • Global OEM Medical Device company
  • Great team culture
  • Competitive compensation package
  • Upward career mobility

Apply for this job

Click the Apply or LinkedIn button below or contact Morgan Bernstein quoting job reference 1219875
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