|Job Title:||Vigilance Specialist|
|Contact Name:||Michael Burgstaller|
|Job Published:||January 15, 2020 14:29|
A dynamic and internationally successful medical device company headquartered in Bonaduz, Switzerland. At Hamilton Medical, we live for ventilation technology. Technology that helps caregivers improve the lives of their critically ill patients. We develop Intelligent Ventilation solutions, devices and consumables.
- 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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