Vigilance Specialist - Bonaduz
|Job Title:||Vigilance Specialist - Bonaduz|
|Contact Name:||Michael Burgstaller|
|Job Published:||January 23, 2020 15:59|
A dynamic and internationally successful medical device companyin the Kanton of Graubünden, Switzerland.
- Interaction with regulatory agencies and partners regarding vigilance cases and ensuring their questions are addressed within established time-frames
- Compilation of investigation details to support global vigilance reporting requirements
- Responsibility for vigilance reports and ensure reports are submitted to regulatory agencies or partners within required timelines
- Definition of safety measures (FSCA), active participation in product recalls and recall communications to markets and health authorities as required
- Keeping up to date with regulatory and normative requirements and ensuring their implementation in day-to-day business
The ideal candidate:
- Technical degree or comparable qualification
- Minimum 3 years professional experience in the Medical Device Industry; preferably in Post-Market Surveillance.
- Practical knowledge in relevant regulations such as 21 CFR 820, MDR, MDD, and ISO 13485 / IEC 60601
- Results oriented, multi-tasker, and quick learner; demonstrated ability to respond to the urgent needs of the team and track record of meeting agreed upon deadlines
- Fluency in English and German language
- CV an: firstname.lastname@example.org
- Phone call and discussion of the job opportunity.
- Guidance through whole interview process and possible discussion of other opportunities.
- E-Mail: email@example.com
- Tel: +41 43 508 92 17
- Xing: https://www.xing.com/profile/Michael_Burgstaller19/cv
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