Location: EU-based, supporting Lyon, France
Salary: €55,000–€65,000 base salary + standard country benefits package
Travel: Some travel required
We are partnering with a global medical aesthetics company to recruit a Risk Manager to join its R&D team. The role will support the Lyon site, but candidates can be based elsewhere in the EU.
The Risk Manager will take ownership of risk management activities across both new product development and existing medical devices, ensuring compliance with relevant regulatory and quality standards.
Lead risk management activities in line with ISO 14971, ISO 13485, EU MDR and Annex XVI.
Support risk management throughout new product development and maintain documentation for existing products.
Identify and evaluate product risks and define appropriate risk control measures.
Ensure risk controls are implemented, verified and validated.
Work closely with R&D, Regulatory Affairs, Clinical, Manufacturing and Human Factors/Usability teams.
Prepare and maintain risk management documentation for regulatory submissions and audits.
Support notified body inspections and internal audits.
Ensure a consistent approach to risk management across projects and throughout the product lifecycle.
Minimum 2 years' experience in the regulated medical device industry.
Hands-on experience with medical device risk management and risk assessment methodologies.
Knowledge of ISO 14971 and EU MDR.
Knowledge of usability or human factors engineering for medical devices.
Master's or Engineering degree in a relevant scientific or technical field.
Fluent English; French would be a plus but is not essential.
Strong communication, organisation and problem-solving skills.
Desirable: Experience with ISO 13485, MDR Annex XVI, medical device manufacturing, FMEAs and regulatory inspections.
This is a great opportunity to join an international medical aesthetics business in a highly collaborative R&D environment, with the flexibility to be based across the EU.
Interviews are kicking off in the first week of September, so if this sounds like the right next step for you, don't delay in applying.
Apply now with your CV, and we'll be in touch to discuss the opportunity in more detail.
