Hiring Now | Regulatory Affairs Specialist – Medical Device
Location: Boston, Massachusetts
Duration: 12+ Months Contract
Industry: Medical Device
We are looking for an experienced Regulatory Affairs Specialist to support regulatory submissions and compliance activities within a fast-paced medical device environment. The ideal candidate should have strong experience with FDA regulations, technical documentation, product registrations, and global regulatory compliance.
Key Responsibilities:
- Support preparation and submission of regulatory documents for FDA and international markets
- Maintain regulatory documentation and product compliance records
- Collaborate with Quality, R&D, and Clinical teams to support product development activities
- Review labeling, change controls, and technical files for regulatory compliance
- Support audits, inspections, and regulatory inquiries
- Ensure compliance with FDA, ISO 13485, and EU MDR requirements
Required Qualifications:
- 4+ years of Regulatory Affairs experience in Medical Devices
- Strong knowledge of FDA regulations and global regulatory requirements
- Experience with 510(k), technical documentation, and compliance activities
- Excellent communication and documentation skills
