Risk Management Specialist
Risk Management Specialist
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Join a leading global pharmaceutical client in supporting critical risk management
activities within innovative medical device development 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.
Tasks
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 workshopsAuthor 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
Requirements
Masters 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
Employment Type
Full Time
