Regulatory Affairs Specialist
Job Title: Regulatory Affairs Specialist
Duration: 12 months (with extension opportunity)
Hours: Full-time (hybrid/remote)
Location: Paris, France
Core Responsibilities
- Design and implement verification and validation protocols that meet international regulatory standards.
- Lead the selection and approval of testing partners under global certification schemes (e.g., IEC, EU MDR, FDA, PMDA, TGA).
- Oversee the preparation and maintenance of technical files and regulatory documentation for product approvals and market access.
- Manage PMS and clinical follow-up programs, ensuring timely reporting to authorities in relevant jurisdictions.
- Coordinate regulatory communications for products under clinical evaluation, including scheduled updates.
- Track changes in regulatory landscapes and ensure documentation remains current and compliant.
- Represent the organisation in standard-setting forums (ISO, ANSI, CEN-CENELEC) to influence industry practices and regulatory policies.
- Support regulatory and quality audits, ensuring alignment with applicable standards and internal procedures.
Required Qualifications
- Degree in Biomedical Engineering, Life Sciences, Regulatory Affairs, or a related discipline.
- 3-5 years of experience in regulatory affairs within the medical device sector.
- Strong background in biocompatibility assessments and regulatory submissions.
- Proficient in English, both written and verbal.
- Solid understanding of ISO 10993, EU MDR, FDA regulations, and risk management frameworks.
- Knowledge of digital health regulations and EHR system integration.
- Regulatory Affairs certification (e.g., RAPS RAC) is an asset.
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your CV so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customised support on how to optimise your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.