Remote Quality Regulatory Affairs Specialist in Redmond

Job is Expired

Location: Washington

Compensation: To Be Discussed

Staff Reviewed: Tue, Jul 27, 2021

Job Category: Healthcare

Remote Level: 100% Remote

Weekly Hours: Full Time

Employer Type: Employer

Career Level: Experienced

Education Level: Bachelors

Job Summary

A leading medical technology company is filling a position for a Remote Quality Regulatory Affairs Specialist in Redmond.

Core Responsibilities Include:

  • Assuring post-market regulatory requirements are met
  • Supporting all necessary reporting activities related to the complaint handling process
  • Interacting with regulatory agencies on vigilance reports and incidents globally

Qualifications for this position include:

  • BS in Engineering, Science, or equivalent work experience
  • Minimum 2 years relevant experience
  • Knowledge of 21 CFR Part 820, Quality System Regulations
  • Knowledge of 21 CFR Part 803, Medical Device Reporting
  • Knowledge of 45 CFR Parts 160 and 164, The Privacy Rule, HIPAA Statute
  • Knowledge of the Medical Device Directive (MDD)

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