Risk Manager
Pubblicato il 16-08-2026 - Sinclair in Roma
Sinclair is Hiring Join Our Team as a Risk Manager. We are currently recruiting for Risk Manager. The Risk Manager will report to the R&D; Director and 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.
Legga la panoramica di questa possibilità per capire quali competenze sono richieste, incluse le soft skill pertinenti e la padronanza di pacchetti software.
About Sinclair: Founded in 1971, Sinclair is a global medical aesthetics organisation delivering 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.
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 according to project phases following all relevant internal procedures, processes, and external requirements.
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 needs and ensure 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 RD