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Regulatory Specialist (contractor)

  • Job type: Contract
  • Location: Santa Clara, California
  • Salary: Competitive
  • Job reference: 279731/001_1551222279
  • Sector: EPM Scientific, Regulatory
  • Date posted: 26/02/2019

Regulatory Specialist (Contract)

A growing medical device company in Santa Clara, CA is looking for a regulatory affairs consultant to join their team for 6-9 months. The regulatory specialist will be working cross-functionally with the quality, regulatory, and project management teams to complete a smooth transition to the new EUMDR.

Responsibilities:

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

  • 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 closely with cross-functional teams.

Requirements:

  • 3-5 years of regulatory affairs experience in the medical device industry

  • 2 years of EUMDR experience

  • Risk management experience

  • Strong working knowledge of ISO13845

  • Post market surveillance experience

Apply now and don't miss your chance to work for a growing company with an excellent teamwork environment!

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