Found Description
Risk Manager – Sinclair
Sinclair is a global medical aesthetics organisation founded in 1971, delivering an extensive product range and manufacturing a wide portfolio of medical devices and aesthetic products across 55 countries. We are actively seeking a Risk Manager to join our R&D team and contribute to regulatory submissions, product launch timelines and ongoing review activities.
Responsibilities
- Lead and coordinate all risk management activities in accordance with ISO 14971, ISO 13485, MDR and Annex XVI.
- Plan, prepare and perform risk management for medical devices and aesthetic products throughout all project phases, following relevant internal procedures and external requirements.
- Represent Risk Management on assigned development projects.
- Establish risk acceptance criteria for individual residual risks and the overall residual risk for new and legacy devices.
- Maintain close collaboration with the H...