Medical Device Regulatory Affairs Specialist
Top Notch Finders
Job Overview
An innovative medical device company is seeking a Regulatory Affairs Specialist to support domestic and international product submissions while ensuring compliance with FDA and global regulatory requirements.
Responsibilities
- Prepare and maintain regulatory submissions and documentation
- Support FDA 510(k) and international product registrations
- Monitor changes to regulatory requirements
- Collaborate with engineering, quality, and clinical teams
- Assist with internal and external audits
- Maintain product technical files and regulatory records
Qualifications
- Bachelor’s degree in Engineering, Life Sciences, or related field
- 3+ years of medical device regulatory experience
- Knowledge of FDA, ISO 13485, and MDR requirements
- Excellent documentation and communication skills
- Detail-oriented with strong organizational abilities