Vigilance Specialist - Medical Device
- Employer
- Barrington James
- Location
- Lausanne, Canton of Vaud (CH)
- Salary
- Competitive, Flexible dependent on experience
- Start date
- 22 May 2023
- Closing date
- 21 Jun 2023
View more
- Discipline
- Quality, Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
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Job Details
- Evaluation of complaints and incidents from medical devices and documentation in the vigilance system Implementation of rule-compliant reports in compliance with reporting obligations and taking into account national and international reporting requirements Interaction with state authorities on reports and corrective measures Initiation of necessary corrective and safety measures in the event of serious incidents in the field Assisting in the continuous improvement of vigilance processes
Participation in risk-benefit assessments after serious incidents Interface management in other areas of the organization to initiate necessary corrective measures
Requirements:
- Successfully completed scientific or technical studies or similar At least 2 years of professional experience in the medical device industry with a focus on vigilance and post-market surveillance In-depth knowledge of applicable regulated national and international requirements for vigilance reporting Practical knowledge of FDA, MDR, ISO 13485 and IEC 60601 regulations desirable Experience in regulatory affairs / approval of medical devices desirable Fluent written and spoken German and English You are a strong communicator both in the team and between interfaces You bring assertiveness and rational decision-making
Company
We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.
Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.
Company info
- Website
- https://barringtonjames.com/
- Telephone
- 01293 776644
- Location
-
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
GB
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