Senior Regulatory Affairs Specialist

Summary

The Senior Regulatory Affairs Specialist supports and executes regulatory activities for medical devices across the product lifecycle, with increasing independence and responsibility. This role is responsible for developing and executing global regulatory strategies, 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 US, EU, APAC, LATAM, and MEA regions and support product development, market clearance/approval, and lifecycle management.

Essential Duties and Responsibilities

Regulatory Strategy & Submissions

Develop and implement global regulatory strategies for medical device products (Class I - II as applicable)

Prepare, compile, and support FDA regulatory submissions, including 510(k)s, De Novo submissions, Technical Documentation (EU MDR), CE Mark submissions, supplements, and amendments, and international registrations.

Lead interactions and correspondence with regulatory authorities.

Contribute to regulatory strategy for new product development, product changes, and line extensions.

Provide regulatory assessment of design changes and determine submission/reporting requirements.

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

Serve as regulatory representative on cross-functional product development teams.

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 related discipline.

Must have at least 8 years of work experience in the medical device industry.

Demonstrated experience preparing or supporting regulatory submissions (510(k) and Technical Documentation experience required).

Experience with U.S., EU, Canada, APAC, LATAM, MEA.

Experience with product registrations and international regulatory activities.

Strong project management skills.

Preferred Qualifications

Regulatory Affairs Certification (RAC) or progress toward certification.

Experience supporting digital health, SaMD, MDDS, or clinical evaluations.

Knowledge & Skills

Strong knowledge of 21 CFR Parts 800???820, 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.