Regulatory Affairs Specialist – Medical Devices

About the Company:
Our client is a leading medical device company dedicated to developing cutting-edge healthcare solutions that improve patient outcomes. With a strong commitment to quality and regulatory excellence, they are seeking a highly skilled Regulatory Affairs Specialist to join their team in the Greater Boston area. This is an exciting opportunity to work in a fast-paced environment and play a crucial role in ensuring compliance with global regulatory requirements.

Job Summary:
As a Regulatory Affairs Specialist, you will be responsible for navigating the complex regulatory landscape for medical devices. You will lead the preparation and submission of regulatory filings, ensure compliance with FDA, EU MDR, and other global regulatory requirements, and serve as a liaison between the company and regulatory agencies. This role requires an in-depth understanding of medical device regulations and the ability to work cross-functionally with internal teams to support product development and market access.

Key Responsibilities:

Regulatory Submissions: Prepare and submit regulatory documents, including 510(k), PMA, De Novo, CE Marking (MDR), and international regulatory submissions to gain product approvals.
Regulatory Strategy: Develop and execute regulatory strategies to facilitate product clearances, approvals, and post-market compliance.
Compliance Monitoring: Ensure compliance with all applicable medical device regulations, including FDA 21 CFR Part 820, ISO 13485, EU MDR, Health Canada, and other global regulatory frameworks.
Regulatory Intelligence: Monitor and interpret changing regulations and industry trends to provide proactive guidance to internal teams.
Liaison with Regulatory Authorities: Act as a primary contact for regulatory agencies such as the FDA, Notified Bodies, and other global regulatory agencies, facilitating meetings and responding to inquiries.
Technical Documentation: Create and maintain Technical Files, Design History Files (DHF), Device Master Records (DMR), and Risk Management Files to support regulatory submissions and compliance.
Post-Market Compliance: Support post-market surveillance activities, including adverse event reporting, vigilance, recalls, and periodic updates to regulatory bodies.
Cross-Functional Collaboration: Work closely with R&D, Quality Assurance, Manufacturing, and Marketing to ensure regulatory considerations are integrated throughout the product lifecycle.
Required Qualifications:

Education: Bachelor’s degree in Biomedical Engineering, Life Sciences, Regulatory Affairs, or a related field (Advanced degrees preferred).
Experience: Minimum of 2-3 years of regulatory affairs experience in the medical device industry.
Knowledge: Strong understanding of FDA regulations (21 CFR Part 820), EU MDR, ISO 13485, IEC 62304, ISO 14971, and international medical device regulatory requirements.