Regulatory Affairs Specialist

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. Essential Duties and Responsibilities Regulatory Strategy & Submissions 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. Regulatory Change Management & Gap Assessments 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. Product Registrations & International Market Expansion 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. Lifecycle & Change Control Support 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. Documentation & Compliance 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. Post-Market Surveillance & Vigilance 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. Cross-Functional Collaboration 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. Job Requirements 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. Preferred Qualifications Regulatory Affairs Certification (RAC) or progress toward certification. Experience supporting digital health, SaMD, MDDS, or clinical evaluations. Knowledge & Skills Working knowledge of 21 CFR Parts 800820, ISO 13485, ISO 14971, EU MDR 2017/745 and applicable international regulatory frameworks. Experience conducting regulatory gap assessments and supporting regulatory change management. Strong technical writing, organizational, and project management skills. Ability to work independently on routine regulatory activities while escalating complex issues appropriately. Proficiency with Microsoft Office and electronic document management systems. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to sit. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually low to moderate.

Created: 2026-03-05