What are the responsibilities and job description for the Senior Regulatory Affairs Specialist position at ACE Partners?
A leading medical device company specializing in surgical and patient positioning solutions is seeking a Senior Regulatory Affairs Specialist to support global regulatory strategies and submissions. This role is critical in ensuring compliance with FDA and international regulatory requirements for a range of medical devices, including sterile, wireless, and cybersecurity-related products.
Key Responsibilities:
- Prepare, compile, and submit regulatory documentation for U.S. and international markets (510(k)s, technical files, annual reports, amendments).
- Maintain regulatory databases and submission timelines.
- Assist with global product registrations and post-market compliance activities.
- Collaborate with cross-functional teams to ensure adherence to regulatory standards (FDA, EU MDR, etc.).
- Support audits and regulatory inspections by preparing necessary documentation and responses.
- Monitor and interpret evolving regulatory requirements to guide internal teams.
Qualifications:
- Bachelor’s degree in a technical field (engineering, biology, chemistry, or related).
- 8–10 years of regulatory affairs experience, with at least 2 years in medical devices.
- Strong knowledge of 21 CFR, FDA guidelines, and international regulations.
- Experience with global product registrations, including post-market requirements.
- Familiarity with regulatory considerations for cybersecurity, wireless, and sterile devices.
Salary : $100,000 - $125,000
