Regulatory Affairs Specialist
Regulatory Affairs Specialist (Freelance)
Location: Lyon, France (hybrid)
Length: 12 months (possibility of extension)
Hours: Full-time (40 hours per week)
Start Date: Mid-August - September 2026
Engagement: Freelance
Key Responsibilities
- Contribute to the development and maintenance of regulatory strategies for both existing and new medical device products, including Class IIb devices.
- Support regulatory project activities in collaboration with cross-functional teams, including R&D, Clinical Affairs, Quality, and Manufacturing.
- Provide regulatory guidance and technical expertise to internal stakeholders on product compliance and regulatory requirements.
- Assist in preparation for regulatory inspections and external audits, including supporting technical documentation reviews for FDA and ISO assessments.
- Work alongside Notified Bodies and support global product registrations, submissions, and regulatory approvals.
- Ensure products remain compliant with applicable regulatory frameworks, quality standards, and internal procedures.
- Follow Quality Management System requirements and support adherence to site EHS policies and procedures.
- Participate in communications with regulatory authorities, Notified Bodies, and other external agencies as required.
Requirements
- Bachelor's degree in a scientific discipline such as Life Sciences, Biology, Chemistry, or a related field.
- Proven experience with Class IIb medical devices is essential; exposure to combination products is highly desirable.
- Previous Regulatory Affairs experience within the medical device, diagnostics, pharmaceutical, or healthcare manufacturing industry.
- Strong understanding of ISO 13485, MDR 2017/745, IVDR 2017/746, MDD, IVDD, EMC requirements, and FDA Quality System Regulations (QSR).
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