Overview

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.

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 for development products.
• Represent Risk Management on assigned development projects.
• Establish risk acceptance criteria for individual residual risks and ...