Regulatory Affairs Specialist

The Regulatory Affairs Specialist supports and executes regulatory activities for medical devices across the product lifecycle, with increasing independence and responsibility. This role contributes to regulatory strategy, prepares and manages submissions and registrations, conducts regulatory gap assessments, and supports international market expansion efforts. The Specialist collaborates cross-functionally to ensure products meet applicable U.S. and global regulatory requirements and supports timely market access and sustained compliance.

• Prepare, compile, and support FDA regulatory submissions, including 510(k) s, De Novo submissions, supplements, and amendments, with minimal supervision.
• Contribute to regulatory strategy for new product development, product changes, and line extensions.
• Draft and coordinate responses to regulatory agency questions, deficiency letters, and requests for additional information.

• Monitor, interpret, and assess the impact of new or revised regulations, standards, and guidance documents (e.g., FDA guidance updates, ISO standard revisions, EU MDR changes).
• Conduct regulatory gap assessments to evaluate current product and quality system compliance against new or evolving regulatory requirements.
• Document gaps, recommend remediation plans, and support implementation of corrective actions in collaboration with Quality, R&D, and other stakeholders.

• Complete and maintain product registrations and listings, including FDA Establishment Registration and Device Listing and international country-specific registrations.
• Support international market expansion activities, including preparation and maintenance of technical documentation (e.g., EU Technical Files, Summary Technical Documentation, country-specific dossiers).
• Coordinate with authorized representatives, distributors, notified bodies, and local regulatory consultants as needed.
• Support CE marking, UKCA, Health Canada, Australia and other global regulatory pathways, as applicable.

• Evaluate regulatory impact of design, manufacturing, labeling, supplier, and software changes.
• Support change control processes by providing regulatory assessments and documentation.
• Assist with product renewals, periodic reports, and ongoing regulatory maintenance activities.

• Maintain regulatory records and databases to ensure submissions, registrations, and approvals are accurate and audit ready.
• Review labeling, IFUs, and promotional materials to ensure compliance with regulatory requirements and approved claims.
• Support internal and external audits and inspections, including FDA inspections and notified body audits.

• Support post-market regulatory activities, including Medical Device Reporting (MDR), vigilance reporting, field actions, and recalls.
• Assist with complaint trend analysis and regulatory reporting related to post-market performance.

• Partner with R&D, Quality, Clinical, Manufacturing, Supply Chain, and Marketing teams to integrate regulatory requirements into product development and commercialization activities.
• Provide regulatory guidance and training to cross-functional teams as needed.

• Bachelor’s degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, Engineering, or a related discipline.
• Must have at least 3-6 years of work experience in the medical device industry.
• Demonstrated experience preparing or supporting FDA submissions (510(k) experience required).
• Experience with EU MDR, UKCA, Health Canada, Australia or other global regulatory frameworks.
• Experience with product registrations and international regulatory activities.

• Regulatory Affairs Certification (RAC) or progress toward certification.
• Experience supporting digital health, SaMD, MDDS, or clinical evaluations.

• Working knowledge of 21 CFR Parts 800–820, ISO 13485, ISO 14971, EU MDR 2017/745 and applicable international…