Risk Management Specialist – Medical Device Development (m/w/d)

Aequor Consulting GmbH - that's us! A young, dynamic and motivated team that aims to bring companies and talents together. We do this both in personnel placement and in personnel staffing. Even with large, complex and international projects, we can rely on the support of over 4,000 colleagues from the headquarters of Aequor Technologies Ltd. We are pleased to support you according to our slogan - “We listen. We deliver."

Join a leading global pharmaceutical client in supporting critical risk management activities within innovative medical device development projects. In this role in Basel, you will play a key part in compiling and revising essential risk management documentation, coordinating cross-functional stakeholders, and ensuring compliance with industry standards to drive product safety and quality.

Your Responsibilities

• Perform risk management activities within assigned device development projects, including the compilation of project Risk Management Plans and hazard identification documents
• Conduct risk assessments covering user-related, design-related, and process-related risks
• Coordinate risk management activities with project team members and technical experts, including facilitation of risk workshops
• Author and review risk management deliverables such as Risk Management Plans, Hazard Identification Documents, Design Risk Assessments, Process Risk Assessments, User Risk Assessments, Risk Management Reports, and Product Quality Control Plans
• Manage incorporation of review comments and ensure successful release of risk documentation in IT systems (e.g., Subway, Polarion, TQW, Agile)
• Support preparation and update of risk management and quality control documents in case of change requests, adopting evaluations as required
• Deliver presentations of Hazard Identification Analysis, Use-Related Risk Analysis, Design Risk Analysis, and Process Risk Analysis with final approved versions in designated systems
• Communicate device and project risks clearly to cross-functional teams and provide design recommendations to mitigate risks
• Support definition of design verification and process control activities

Your Profile

• Master’s degree in Engineering or related fields such as Mechanical, Process, Electrical, Computer, or Medical Engineering, or equivalent experience
• Knowledge of risk management standards, especially ISO 14971 or comparable frameworks, is advantageous
• Experience in medical device development or the pharmaceutical industry is a plus
• Strong command of English (both written and spoken); German language skills are beneficial
• Excellent team player with intercultural awareness and self-motivated work ethic
• Strong communication skills and ability to coordinate effectively across multidisciplinary teams

Benefits

• Work on impactful projects in the evolving field of medical devices within a global pharmaceutical environment
• Collaborate with diverse teams and technical experts worldwide
• Flexible remote working arrangements aligned with CET time zone
• Gain experience in comprehensive risk management processes and regulatory compliance
• Support professional development in a dynamic, innovation-driven setting