Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Monday - Friday, 8:30 am - 5:00 pm

The Senior Regulatory Affairs Specialist is responsible for ensuring compliance with all applicable worldwide regulatory requirements and standards, and for obtaining and maintaining necessary product approvals, registrations, and device listings. Provides regulatory strategy, concurrent planning, status, review, and oversight of Argen products to ensure complete, accurate, and compliant documentation across all countries of distribution. Creates, reviews, maintains, and updates regulatory documentation throughout the product lifecycle.

This role serves as a key regulatory leader, guiding global regulatory strategy, market access readiness, and compliance with complex regulatory frameworks including EU MDR 2017/745 and UK MDR/UKCA.

Develop and implement global regulatory strategies for new product development, product modifications, and market expansion, supporting timely market access and business objectives.

Prepare and submit regulatory submissions, including FDA 510(k) s, EU MDR Technical Documentation, UKCA submissions, and other global regulatory filings, ensuring accuracy, completeness, and adherence to applicable requirements.

Lead and support compliance activities under EU MDR 2017/745 and UK MDR, including Technical Documentation, clinical evaluation oversight, PMS alignment, and coordination with Notified Bodies and regulatory entities.

Provide regulatory oversight and review of Clinical Evaluation Reports (CERs) and related clinical documentation to ensure alignment with regulatory requirements, risk management, and intended use.

Lead regulatory review and approval of labeling and IFU updates, ensuring compliance with EU MDR, UK MDR, FDA, and other applicable regulations.

Manage and maintain global product registrations, device listings, licenses, and certificates, ensuring timely renewals, variations, and continued market access.

Liaise with regulatory authorities and notified bodies to facilitate timely review and approval of regulatory submissions, and to address questions and requests for additional information.

Manage and maintain product registrations, licenses, and certificates for domestic and international markets, ensuring timely renewals and updates.

Provide guidance and support to cross‑functional teams on regulatory requirements and standards, ensuring regulatory compliance throughout the product lifecycle.

Conduct regulatory impact assessments and risk analysis to evaluate and mitigate potential regulatory risks and challenges.

Develop and maintain regulatory affairs procedures and processes to ensure consistent compliance with regulatory requirements.

Support regulatory inspections and audits, including preparation, coordination, and response to findings and observations.

Collaborate with cross‑functional teams to assess the impact of design changes, labeling updates, and manufacturing process changes on regulatory compliance.

Train and mentor regulatory affairs team members, fostering their professional growth and development.

Establish and maintain relationships with key stakeholders, including regulatory authorities, industry associations, and trade organizations.

Develops and implements regulatory standards related to company metrics.

Ensures regulatory initiatives are in place and functional in the facilities and provides training and education as necessary.

Ensures timely submission of all reporting data to maintain compliance with all regulatory agencies.

Creates and reinforces a culture of teamwork and actively resolves conflicts within the team.

Ensures compliance with established policies and procedures.

Inspires and motivates staff to ensure a very high level of performance.

Other duties as assigned.

Bachelor's degree in technically relevant field (Engineering, microbiology, etc.) preferred, and a 10 years' experience in the medical device industry or equivalent combination of education, training, and experience.

In-depth knowledge of global regulatory requirements and standards, such as FDA regulations, ISO…