Risk Manager

Risk Manager

Location: Lyon, France. Reports to the R&D Director. Responsible for maintaining risk management activities for legacy devices and supporting new product development, ensuring regulatory submissions, launch timelines, and regular review activities.

Responsibilities

• Lead and coordinate all risk management activities according to ISO 14971, ISO 13485, MDR, and Annex XVI.
• Plan, prepare and perform risk management for medical devices and aesthetic products following all relevant internal procedures, processes and external requirements.
• Represent Risk Management on assigned development projects and establish risk acceptance criteria.
• Maintain close link to Human Factors / Usability Engineering to ensure safety of all users and patients.
• Support creation of device design specifications and monitor implementation, verification and validation of risk control measures.
• Maintain knowledge of company policies, standards, guidelines and industry practices.
• Ensure harmonized approaches to risk management across projects and communicate lessons learned.
• Ensure risk management processes incorporate data from Design Authorities including FMEAs, Security Risk Analysis, Use‑related risk analysis, formative human factors evaluations and validation studies.
• Prepare timely risk management reports in accordance with ISO 14971 and company SOPs.
• Present risk management activities at regulatory inspections and internal audits.
• Work cross‑functionally with Global Marketing, Global Regulatory Affairs, Clinical Affairs and Manufacturing.
• Support the link between risk management during development and for marketed products.
• Ensure hazards are identified, risks evaluated and controlled, and implementations verified.
• Ensure company quality and compliance standards are met through independent risk management.
• Assist medical device sites in performing risk management for new introductions and inspections.
• Ensure devices and products are designed to be safe, effective and compliant worldwide.

Qualifications

• Minimum of 2 years’ experience in the regulated medical device industry.
• Knowledge of usability engineering or human factors engineering for medical devices.
• Experience with risk assessment methods.
• Master’s degree in Engineering or equivalent in Materials, Biomaterials, Chemistry, Biochemistry, Biology.
• Fluent in English.

Desired Skills

• Experience in the manufacture of medical devices.
• Good knowledge of medical standards: ISO 14971:2019, ISO 13485:2016, MDR, Annex XVI (MDR).
• Experience performing risk management for medical devices.
• Understanding of potential sources of risk and how to manage them.
• Flexibility and adaptability to changing priorities.
• Goal‑oriented, proactive, ability to complete projects and meet deadlines.
• Excellent communication and presentation skills.
• Team player, decision maker, problem solver.
• Attention to detail, interpersonal skills, empathy.

Perks & Benefits

• Competitive salary & performance bonuses.
• Career growth & learning opportunities.
• Health & wellness benefits.
• Fun team events & supportive culture.
• Bonus based on performance objectives.
• Healthcare.
• Lunch tickets.
• Outsourced benefits package.

Location

Sinclair France SAS, Chem du Jubin, Dardilly 69570.

EEO Statement

Sinclair is an equal opportunities employer and accepts no speculative or unsolicited CVs from recruitment agencies. By applying, you consent to the use of your personal information for automated decision‑making processes related to key job requirements.