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.