Offer summary
Qualifications:
Bachelor’s Degree in Engineering or Science, 7+ years in FDA regulated industry, 3+ years Medical Device Regulatory Affairs experience, RAC certification or Advanced Degree preferred, Thorough understanding of regulations.
Key responsabilities:
- Support Joint Replacement Robotics product development
- Ensure compliance with global regulatory requirements
- Assess regulatory impact of device changes post-launch
- Develop and update regulatory strategies
- Prepare and submit regulatory documentation