Risk Manager

Risk Manager

Location: Sinclair France SAS, Chem du Jubin, Dardilly 69570, Lyon, France.

Founded in 1971, Sinclair is a global medical aesthetics organisation that delivers an extensive product range in over 55 countries.

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 throughout project phases, following all relevant internal procedures, processes and external requirements for development products.
• Represent Risk Management on assigned development projects.
• Establish risk‑acceptance criteria for individual residual risks and the overall residual risk for specific devices in development and for legacy devices.
• Maintain a close link to the Human Factors / Usability Engineering process to meet the needs and ensure the safety of all users and patients.
• Support creation of device design specifications to ensure risk‑control measures are appropriate.
• Monitor that risk control measures have been implemented, verified and validated.
• Maintain knowledge of current company policies, standards, guidelines, industry practices and regulatory requirements.
• Ensure harmonised approaches to risk management across projects and communicate lessons learned with the R&D team.
• Ensure the risk management process incorporates all relevant data from Design Authorities (e.g., Design FMEAs, Security Risk Analysis, Use‑related risk analysis, formative human factors evaluations and validation studies).
• Ensure risk management reports are prepared in a timely manner according to ISO 14971 and applicable company SOPs and guidelines and are adequate for inspection by notified bodies and authorities.
• Present project‑specific risk management activities at regulatory body inspections and internal audits.
• Work cross‑functionally with other global functions such as Global Marketing, Global Regulatory Affairs, Clinical Affairs and Manufacturing.
• Support a good link between risk management during development and risk management for marketed products.
• Ensure all hazards associated with a medical device and aesthetic product are identified, the associated risks are estimated and evaluated, and that these risks are controlled; monitor that risk controls are implemented, verified and validated.
• Assure that company quality and compliance standards and applicable government regulations are met through independent risk management for medical devices under development.
• Perform risk management in medical device and aesthetic projects and assist medical device sites in ensuring risk management is performed in sufficient detail and in a timely manner for new device introductions and regulatory agency inspections.
• Has overall responsibility that medical devices and aesthetic products are designed to be safe, effective and in compliance with applicable regulations worldwide.

Qualifications

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

Desirable

• Experience in the manufacture of medical devices.
• Good knowledge of medical standards: ISO 14971:2019, ISO 13485:2016, MDR, Annex XVI (MDR).

Role Competencies

• Experience in performing risk management for medical devices.
• A general understanding of potential sources of risk and how to manage them.
• Flexibility in approach and ability to adapt to changing circumstances and priorities.
• Highly self‑responsible, goal‑oriented and proactive, with ability to complete projects and meet deadlines.
• Excellent communication and presentation skills, to inform and persuade both in speaking and in writing.

General Competencies

• Excellent team player, decision maker and problem solver.
• Patient and understanding.
• High level of attention to detail.
• Strong interpersonal skills and sensitivity.
• Empathetic.

Benefits

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