Remote EU MDR Regulatory Affairs Specialist in Boston

Job is Expired

Location: Massachusetts

Compensation: Salary

Staff Reviewed: Fri, Sep 17, 2021

Job Category: Healthcare

Remote Level: 100% Remote

Weekly Hours: Full Time

Employer Type: Staffing Agency

Career Level: Experienced

Education Level: Bachelors

Job Summary

A staffing agency is in need of a Remote Regulatory Affairs Specialist in Boston.

Core Responsibilities Include:

  • Ensure project plans and deliverables are compliant with appropriate design control procedures
  • Review and approval of documentation
  • Participate in cross functional teams to discuss and revise documents to meet MDR requirements

Qualifications Include:

  • At least 5 years of medical device industry experience in a regulatory affairs position
  • A minimum BA/BS Degree
  • Knowledge of U.S. FDA and EU MDD & MDR medical device regulations and guidances is required
  • Previous experience of EU Notified Body submissions

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