Risk Manager Medical Devices

Project overview

We are looking for a proactive person who will independently handle risk management tasks in compliance with standards and provide strong support to the existing risk management team.

Responsibilities

• Ensuring the risk management process in accordance with valid standards and regulations
• Planning, preparing, and following up on risk analyses, as well as moderating risk analysis meetings
• Creating risk/benefit assessments in collaboration with clinical specialists
• Evaluating post-market information and deriving and tracking risk-related measures
• Ensuring complete risk management documentation
• Maintaining and further developing the risk management process and associated tools

Requirements

SThree_Germany is acting as an Employment Business in relation to this vacancy.

• Successfully completed studies in engineering or a comparable qualification
• Sound experience in product risk management
• Experience in moderating and documenting risk assessments
• Experience with the relevant standards (DIN EN ISO 14971, 13485, UL60601-1) in the field of medical technology is desirable
• Basic knowledge of normative requirements for the approval of medical devices
• Knowledge of Polarion is an advantage
• Very good MS Office skills
• Team-oriented, communicative, analytical, and independent way of working
• Enjoy working with international colleagues
• Good German and English skills (spoken and written)

Project details

• Start: 2027-01
• Duration: 12 Monate
• Remote: remote
• Location: Rastatt, Deutschland, DE
• Languages: German