Description
Sinclair is hiring a Risk Manager to lead and coordinate risk management activities for medical devices and aesthetic products across legacy and new product development. The role supports regulatory submissions and launch timelines, applies ISO 14971, ISO 13485, MDR, and Annex XVI requirements, establishes risk acceptance criteria, monitors risk controls, prepares regulatory-quality reports, and collaborates with R&D, regulatory, clinical, marketing, and manufacturing teams. Candidates need at least two years of regulated medical device experience, knowledge of usability or human factors engineering and risk assessment methods, a relevant engineering master's degree or equivalent, and fluent English.
