Job Summary
A clinical and scientific staffing company is searching for a person to fill their position for a Remote Senior Medical Device Reporting Regulatory Affairs Specialist.
Core Responsibilities of this position include:
- Providing regulatory support for changes to existing products
- Ensuring personal understanding of all quality policy/system items that are personally applicable
- Supporting post market regulatory compliance activities for US/EU product approvals
Qualifications for this position include:
- Bachelor's Degree
- 4+ years of Quality Assurance or Regulatory Affairs experience in medical device
- Knowledge of Medical Device Quality Systems (21 CFR 820, ISO13483) and/or Pharmaceutical GMP
