Job Title: Regulatory Affairs Specialist

Work Location: Baldwin County, New York

Summary:

This position is responsible for supporting regulatory submissions, maintaining compliance with regulatory standards, and collaborating with cross-functional teams to ensure successful product approvals and ongoing regulatory compliance within the medical device industry.

Responsibilities:

• Prepare, format, and collect documentation for regulatory submissions, ensuring accuracy and completeness of files and device registrations.
• Respond to regulatory agency requests for additional information and support post-market submissions such as progress and annual reports.
• Assess regulatory impact of changes in marketing, R&D, and manufacturing, and communicate with distributors regarding regulatory inquiries and filings.
• Collaborate with Quality Assurance to maintain compliance with FDA 21 CFR 820, ISO 13485, and EU MDR 2017/745, and support audit preparation.
• Maintain document control and recordkeeping systems to ensure integrity and traceability of regulatory documentation.
• Work with Engineering and Clinical teams to gather information for submissions, track deliverables, and ensure timely submission of regulatory documents.
• Create and manage regulatory documentation for customer requests, including regulatory letters, certifications, and technical packages for tenders and pre-market clearance.
• Contribute to continuous improvement initiatives, process optimization, and regulatory information system maintenance, while supporting training and compliance awareness efforts.

Qualifications:

• Bachelor's degree in biomedical, regulatory affairs/quality assurance, or a related scientific field (RAC certification preferred).
• Master’s degree in a related field may substitute for 1 year of relevant experience.
• 3-5 years of experience in a regulated FDA environment, specifically within the medical device industry.
• Hands-on experience with 510(k) submissions; knowledge of IDE and PMA processes is a plus.
• Familiarity with FDA, EU MDR, or ISO regulatory environments preferred.
• Experience contributing to audits is preferred.
• Strong organizational, communication, and planning skills, with the ability to work independently or as part of a team.
• Proficiency with PC systems and office applications.
• Detail-oriented, practical, and proactive problem-solving abilities.
• Ability to interact cross-functionally across departments and organizational levels.
• Solid understanding of scientific principles as applied to regulatory affairs.
• Ability to engage and collaborate with cross-functional team members to meet regulatory and business needs.

Published Category: Regulatory Affairs