Senior International Regulatory Affairs Specialist - Orthopedic Medical Device
Location: Greater Boston, MA
We are seeking a Senior International Regulatory Affairs Specialist to join a leading orthopedic medical device company in the Greater Boston area. This role will be responsible for developing and executing global regulatory strategies to support product registrations, market access, and compliance across key international markets.
Key Responsibilities:
- Lead international regulatory submissions, including CE Mark (MDR), Health Canada, TGA, PMDA, and other global markets.
- Collaborate with cross-functional teams to ensure regulatory compliance for new product introductions and lifecycle management.
- Monitor and interpret global regulatory requirements, providing strategic guidance to internal teams.
- Support interactions with international regulatory agencies and notified bodies.
- Maintain regulatory documentation and support audits as needed.
Qualifications:
- Bachelor's degree in life sciences, engineering, or related field.
- 5+ years of regulatory affairs experience in the medical device industry, with a focus on international markets.
- Strong knowledge of EU MDR, ISO 13485, and global medical device regulations.
- Experience with Class II and/or Class III orthopedic devices preferred.
- Excellent communication and project management skills.
If you're a regulatory professional looking to make an impact in a growing orthopedic company, we'd love to hear from you!
