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Regulatory Specialist II (Contract)

  • Job type: Contract
  • Location: Marlborough, Massachusetts
  • Salary: Competitive
  • Job reference: 299591/001_1556915239
  • Sector: EPM Scientific, Regulatory
  • Date posted: 03/05/2019

Regulatory Affairs Specialist II (Contract)

One of the leading medical device companies in the US is looking to bring on a Regulatory Affairs/MDR Specialist for a 4-5 month contract who will be responsible for the international regulatory activities. The candidate will have a strong focus on the EU, along with a few other regulatory agencies. This is medical device company in the Greater Boston Area.

Responsibilities:

  • Strong working knowledge of US FDA Regulations and EU medical device directives

  • Hold experience with international submissions, specifically drafting and writing EU technical files

  • Demonstrate and apply knowledge of up to date EUMDR principles

  • Conduct GAP analysis to identify major changes from Medical Device Directive (MDD) to EU Medical Device Regulations (MDR) and implementing the changes; facilitating smooth transition to EU MDR.

  • Prepare annual reports, letter-to-file, and support in product registrations for international markets.

  • Worked with cross-functional teams to obtain required documents.

  • Maintain multiple projects

Qualifications:

  • 2-4 years of experience in regulatory affairs

  • 2+ years of working in the medical device industry

  • Strong working knowledge of the transition to EUMDR

  • Experience with 510k and PMA submissions

  • Technical writing experience

  • Bachelor's Degree in the life sciences

Apply now - don't miss your chance to work for a smaller, but still market-leading med device company!

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