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)
