Risk Manager

Sinclair is Hiring!

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
• Knowledge in usage of risk assessment methods
• Masters Degree of Engineering degree in the following fields or equivalent (Materials, Biomaterials, Chemistry, Biochemistry, Biology)
• English:
  Fluent

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. This is a great time to join Sinclair as we continue to increase our product range and expand into new markets and territories.

• Act with Integrity Consistently doing the right thing even when it’s the hard choice; 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; it should make a meaningful impact
• Innovation-Centered Redefining Aesthetics, we must be pioneering in how we do business; this can be in products, in service models, or strategy
• Own It! Be Accountable for your decisions, actions and consequences;
  Be Reliable to your customers and colleagues

• 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 according to 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 that risk control measures are appropriate.
• Monitor that risk control measures have been implemented, verified, and validated.
• Maintain knowledge of current Company policies, standards and guidelines as well as industry practices, regulatory requirements, and other relevant information.
• 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.
• Ensure that risk management reports are prepared in a timely manner and in accordance with ISO 14971 and applicable Company SOPs and guidelines and are adequate for inspection by notified bodies and other relevant authorities.
• Present project-specific risk management activities at regulatory body inspections and internal audits.
• Work cross-functionally with other global functions: e.g., Global Marketing, Global…