We are looking for a Regulatory Affairs Manager, on behalf of an international client company based in Haute-Savoie (France) and specialized in injectable medical devices. Attached to the Quality, Regulatory, and Clinical Director, you will be responsible for regulatory affairs management throughout the product lifecycle, from conception to market monitoring.
Your main missions are as follow :
- Manage the Regulatory Affairs team and coordinate activities.
- Ensure regulatory and normative monitoring:
- Ensure regulatory and normative monitoring of products distributed in Europe and internationally,
- Identify the list of standards/regulations applicable to activity and verify their consideration,
- Coordinate monitoring activities with other functions within the company.
- Manage CE Marking files :
- Draft technical CE Marking files and make market placement declarations,
- Ensure the technical file is kept up to date,
- Ensure post-CE marking maintenance of Technical Files (RMF) and usability,
- Drive the regulatory evaluation process of changes and their communication to the notified body/competent authorities.
- Act as regulatory representative in the design process:
- Propose and implement suitable technical and regulatory strategies,
- Manage the list of standards applied per product range,
- Provide regulatory support throughout the Design process.
- Manage export registrations :
- Draft regulatory registrations and coordinate with international counterparts,
- Handle regulatory and technical queries from health authorities following registration dossier submission,
- Ensure license tracking and maintenance.
- Manage dossier variations with international counterparts.
To successfully carry out this mission, we are seeking a candidate with a scientific higher education background (Master's degree level), with at least 10 years' experience in a Regulatory Affairs department within the medical device (class III or IIb) or pharmaceutical industry.
You have proven experience in Management and master the standards and regulations applicable to medical devices (ISO 13485; Directive 93/42 EEC, MDR 2017/745,…).
You speak fluent English and French is a real asset Are proficient in computer tools (office applications).
Your analytical and synthesis skills, discretion, and objectivity are among your strengths. You are also known for your organizational skills, as well as your interpersonal and writing abilities.