Description
Risk Manager - Medical device Technical ExpertI would like share our current Job with you:
Positions: Risk Manager - Technical Expert
Market: Medical Device
duration: to Months)
Locations: Basel
If you are interested, please see further details below or contact me directly.
I am looking forward to hear from you.
An qualified candidate you have a relevant degree in engineering
- 7 years of experience in a similar position, in the life science industry
- 2-3 years of experience as medical device
- Broad experience in risk management team leader
- Experience in managing risk management files Good training and presentation skills, technical knowledge of parenteral packaging
- Experience of Development medical devices, combination products Awareness of Human Factors Engineering/usability Development experience including Design Control process and other applicable regulatory,
- QA and GMP aspects Experience of managing external suppliers
- Education: Master degree in Science/Engineering or Mechanical Engineering or University level Engineering education
- Language: Excellent skills in English language are required. Proficiency in German advantageous. Other language skills, e.g. French, advantageous.
- Main Tasks * Lead specific risk management activities within projects, as agreed with project leaders
- Facilitate development and completion of risk assessments.
- Ensure timely completion and quality of the assigned risk management files.
- Manage the overall Risk Management Program of the packaging and device development activities for within the team.
Other Tasks
- Ensure compliance with ISO 14971 in all development projects under responsibility of our team.
- Supervise risk management activities in all development projects under responsibility of our team.
- Harmonize the medical device risk management outputs across all development projects under responsibility of our team.
- Supervise and train junior experts and other team members on Risk Management in line with local procedures and regulatory standards.
- Conduct and provide guidance on the use of risk analysis for Use, Products, Components and Processes.
- Ensure compliance with regulatory and normative guidelines focusing on medical device risk management
- Shape and improve the current internal risk management process for medical devices Guide internal and external functions on creating, reviewing and approving medical device Risk Management Files.
- Work with device development team to incorporate and complete Risk Management during all design phases for new and/or product enhancements.
- Apply FDA CFR 820, ISO13485, and ISO 14971 Risk Management in assigned projects.
Please get back to me regarding any other questions.
Best Regards
S.KEEL