Help bring innovative, software‑driven respiratory devices to patients by guiding them through global regulatory pathways.
Proclinical is seeking a Regulatory Affairs Specialist to support the development and global deployment of innovative medical devices in the respiratory care space. This role offers an exciting opportunity to contribute to the regulatory certification and market entry of cutting‑edge software‑driven medical devices. You will work within a dynamic, multidisciplinary team in a fast‑paced environment, ensuring compliance and safety throughout the product lifecycle.
Responsibilities
- Plan, prepare, and submit regulatory applications and technical documentation for medical devices in priority markets, including the USA, EU, Canada, Middle East, Brazil, and China.
- Author, review, and maintain technical documentation in line with applicable regulations and internal procedures.
- Collaborate with external agencies to develop strategies, provide advice, and support audits and inspection readiness.
- Act as the primary liaison with regulatory bodies, managing correspondence, participating in meetings, and coordinating external audits.
- Monitor global regulatory requirements, summarize changes, and communicate impacts and recommendations to internal stakeholders.
- Project manage regulatory initiatives to ensure timely and budget‑conscious delivery.
- Serve as a subject matter expert on regulatory affairs, integrating compliance considerations across the medical device lifecycle.
- Manage post‑market surveillance processes and mandatory regulatory submissions, such as PSURs and Trend Reports for the EU.
Key Skills and Requirements
- Strong technical writing skills with the ability to produce clear and concise regulatory documents.
- Excellent written and verbal communication abilities.
- Exceptional attention to detail.
- Proven experience in successfully obtaining FDA clearance (510k or de novo).
- Knowledge of FDA cybersecurity requirements and their application to secure design.
- Proficiency in ISO 13485, 21 CFR 820, ISO 14971, IEC 62304, IEC 60601‑1 series, and IEC 62366 standards.
- Effective regulatory project management skills with a track record of delivering cross‑functional projects on time.
- Familiarity with generative AI and automation tools to enhance productivity in regulated environments.
- Willingness to learn, adapt, and develop both processes and personal skills.
Qualifications and Experience
- Bachelor's degree or higher in STEM or a related field.
- Hands‑on experience in regulatory affairs within the medical device industry, including preparation and management of submissions for multiple international markets.
- Successful certification of SaMD devices at class II or class III.
- Demonstrated success with FDA de novo or 510k submissions via the eSTAR program.
- Experience with regulatory approvals in at least two of the following regions: Canada, EU, Japan, Brazil, Middle East, or China.
- Comfort working independently in a fast‑paced, growth‑stage organization while building and refining processes.
Additional Information
- Legally eligible to work in the UK without sponsorship. Sponsorship may be considered for transitioning to a Skilled Worker Visa after probation.
- Ability to work in person at the Cambridge office at least three days per week.
Contact: Joe Dykes at j.dykes@proclinical.com.
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