Job Description

Job Title: Regulatory Affairs Specialist

Location: Boston , MA
Duration: 18+ Months

Job Description:
The Regulatory Affairs Specialist will be responsible for ensuring that the company complies with all regulations and laws pertaining to its business. The ideal candidate will manage and execute the preparation of regulatory submissions, maintain regulatory compliance, and provide support for new product development and market expansions. You will work closely with cross-functional teams to ensure documentation is complete, accurate, and submitted in a timely manner.

Key Responsibilities:

• Prepare, review, and submit regulatory filings to the FDA, EU, and other global regulatory bodies.
• Ensure products meet regulatory requirements and manage regulatory approvals for product launches.
• Maintain current knowledge of relevant regulations, including FDA, ISO, and other international standards.
• Collaborate with R&D, Quality, and Manufacturing teams to support regulatory strategies for product development and design changes.
• Liaise with regulatory authorities and manage communications regarding product registrations and compliance.

Required Skills:

• Strong understanding of FDA regulations, ISO 13485, and global regulatory guidelines.
• Experience with regulatory submissions (510(k), PMA, CE Marking, etc.).
• Excellent communication skills and the ability to interact with regulatory agencies.
• High attention to detail with strong organizational and project management abilities.
• Knowledge of medical devices, pharmaceuticals, or related industries.

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