Professional Risk Manager

Project overview

For our client, we are looking for a Professional Risk Manager (m/f/d) Medical Devices starting in July for consulting services in the project:

Responsibilities

• Analysis, maintenance, and continuous optimization of existing risk management processes according to ISO 14971, ISO 13485, and applicable regulatory requirements.
• Creation, revision, and maintenance of risk management documentation, for example:
• Risk Management Plans
• Risk Analyses
• Risk Assessments
• Benefit-Risk Assessments
• Traceability Evidence
• Risk Management Reports
• Technical consulting for new product developments and modifications of existing medical devices and software solutions by:
• Identifying potential hazards
• Risk assessment
• Deriving suitable risk mitigation measures
• Evaluation of product changes, customer feedback, complaints, incidents, post-market surveillance data, CAPA measures, and cybersecurity-relevant information regarding their influence on existing risk profiles
• Assessment of the effectiveness of implemented risk controls, including documentation of remaining residual risks
• Identification of gaps, inconsistencies, and missing evidence within existing Risk Management Files and development of prioritized recommendations for action
• Technical exchange with the departments:
• Regulatory Affairs
• Quality Management
• Product Management
• Development
• Clinical Evaluation
• Post-Market Surveillance

Requirements

• Several years of practical experience in medical device risk management throughout the entire product lifecycle
• Demonstrable knowledge of the standards:
• ISO 14971
• ISO 13485
• European regulatory requirements for medical devices
• Experience in setting up, maintaining, and reviewing complete Risk Management Files
• Experience in evaluating complaints, incidents, product changes, and post-market data from a risk management perspective
• Profound knowledge of established risk methods such as:
• Hazard Analysis
• FMEA
• Fault Tree Analysis
• Benefit-Risk Assessment
• Experience with software-based medical devices or Software as a Medical Device (SaMD), including safety, usability, and cybersecurity risks

Project details

• Start: 2026-11
• Duration: 2 Monate
• Remote: remote
• Location: Mannheim, Deutschland, DE
• Languages: German