Join Our Team as a Risk Manager We are currently recruiting for Risk Manager. The Risk Manager will have reports into the R&D; Director to contribute directly to meeting regulatory submission, launch timelines of medical devices and aesthetic products as well as regular review activities. The Risk Manager is responsible to maintain risk management activities for legacy devices and to support new product development activities. Minimum of 2 years of experience in regulated medical device industry Knowledge of usability engineering or human factors engineering for medical devices English: About Sinclair Founded in 1971, Sinclair is a global medical aesthetics organisation, that delivers an extensive product range. With an in-house commercial infrastructure, including manufacturing and a network of distributors in leading global markets, our products are sold in 55 countries worldwide. 100% Compliance with all rules, standard operating procedures and guidelines Results-Driven Make a business impact in all you do, whether sales, efficiency, operational excellence; Innovation-Centered Redefining Aesthetics, we must be pioneering in how we do business; this can be in products, in service models, or strategy Plan, prepare and perform risk management for medical devices and aesthetic products according to project phases following all relevant internal procedures, processes, and external requirements for development products. Represent Risk Management on assigned development projects. Support creation of device design specifications to ensure that risk control measures are appropriate.



Monitor that risk control measures have been implemented, verified, and validated. Ensure harmonized approaches to risk management across projects. Communicate with Research and Development team members on other projects to share lessons learned and ensure use of common tools and ideas within the team. Ensure that the risk management process incorporates all relevant data from the Design Authorities e.g., Design FMEAs, Security Risk Analysis, Use-related risk analysis, formative human factors evaluations and human factors validation studies. Present project-specific risk management activities at regulatory body inspections and internal audits. Work cross-functionally with other global functions: e.g., General Marketing, Global Regulatory Affairs, Clinical Affairs and Manufacturing. Support a good link between risk management during development and risk management for marketed products. Ensure that all hazards associated with a medical device and aesthetic products are identified, the associated risks are estimated and evaluated and that these risks are controlled; monitors that these risk controls are implemented, verified and validated.



Assures that Company quality and compliance standards and applicable government regulations are met by means of independent risk management for medical devices under development. Performs risk management in medical device and aesthetic projects and assists medical device sites in ensuring that 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 the applicable regulations worldwide. Minimum of 2 years of experience in regulated medical device industry Knowledge of usability engineering or human factors engineering for medical devices English: Experience in the manufacture of Medical Devices Experience in performing risk management for medical devices A general understanding of the potential sources of risk and how to manage 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 The company is full of opportunity for those who wish to grasp it. Our people thrive on engagement, development and a varied workload. You will often be included in projects that require you to collaborate cross‐functionally. This is an exciting opportunity to join a successful company, with big ambitions for the future.

📌 Risk Manager (Comunidad de Madrid)
🏢 Sinclair
📍 Comunidad de Madrid