Staff Regulatory Affairs Specialist (EU MDR)

Catalyst

Staff Regulatory Affairs Specialist (EU MDR)


  Franklin Lakes, New Jersey
Posted
3 weeks ago
Duration
Permanent
Salary
$125,000 - $150,000
Sector
Regulatory Affairs

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This is an opportunity to join a well funded growing medical device company who manufacture diabetes devices; who are looking for a remote Senior Regulatory Affairs Specialist to join their team. You’ll write and update EU MDR technical files on their existing products whilst having the opportunity to also work on product labelling.

 

Responsibilities will include:

  • Assist with updating product labelling.
  • Writing and update 510k submissions accordingly for any product changes.
  • Write and update EU MDR technical documentation in order to support CE mark submission.
  • Communicating and liaising with regulatory bodies to ensure products are compliant.
  • Obtaining CE marking/certification for the EU market, and FDA approval for the US market.

 

Ideal Candidate:

  • 5+ years’ experience technical writing within Regulatory or Clinical Affairs within Medical Devices.
  • Proven ability to write comprehensive technical files.
  • Has had experience writing and updating EU MDR technical files.
  • Experience negotiating and registering products with different regulatory bodies.

We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.

Callum.Sparkes

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Contact

Email
+44 (0) 20 3589 9300
 

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