Regulatory Affairs MDR Specialist

Location: Massachusetts

Compensation: To Be Discussed

Staff Reviewed: Wed, Nov 04, 2020

This job expires in 0 days

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 and recruitment agency is in need of a Regulatory Affairs MDR Specialist.

Core Responsibilities of this position include:

  • Collaborate with stakeholders to develop and maintain project plans
  • Execute projects in accordance with the cadence
  • Create, monitor and analyze project risks and identify mitigation strategies

Required Skills:

  • A minimum BA/BS Degree with at least 5 years of regulated medical device industry experience
  • Knowledge of orthopedic implants a plus
  • Knowledge of U.S. FDA and EU MDD & MDR medical device regulations and guidances is required
  • Demonstrated experience with planning, oversight, and execution of multiple projects is required; project management training & certification is a plus
  • Familiarity with international regulations and guidance (such as China, Brazil, Japan, etc.) a plus