Global Team Leader - IVDR
Candidates located accros EuropeFull-TimeManager
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- Four years professional experience in the TIC industry
- Required Skills
- Project ManagementComplianceTeam management
Requirements
- University or technical college degree in Microbiology, medicine, pharmacy, engineering or relevant sciences.
- Four years professional experience in the TIC industry in healthcare products/related activities.
- Two years experience in design, manufacture, testing or use of the device or technology.
- Proven management experience of global teams.
- Strong project management skills.
- Extensive working knowledge of IVDR medical device management systems and compliance.
- Knowledge of conformity assessment procedures and legislation.
- Ability to draw up records and reports demonstrating conformity assessment activities.
Responsibilities
- Lead the team of IVDR product assessors and IVDR IHC.
- Manage the in vitro diagnostic medical device training process.
- Develop, update and maintain QMS documentation related to in vitro diagnostic medical devices.
- Provide technical lead and expertise to the global Medical Devices network.
- Liaise with regulatory authorities and certification bodies on technical and regulatory questions.
- Support the recruitment, assessment and approval process of auditors and product assessors.
- Contribute to the business development of in vitro diagnostic medical devices activities.
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