Vigilance Specialist - German Switzerland - High Tech products
Vigilance Specialist - Eastern Switzerland - High Tech products - English a MUST, German useful
Our client is a globally active medical devices manufacturer - in a leading market position, growing, and with it the Quality department. On top of their 'wanted' list is a Vigilance specialist - a key role going forward, in addressing complaint and vigilance reporting processes, and ultimately in reducing the complaints themselves.
More specifically, this role will hold responsibility for vigilance reporting and assurance of the submission of the reports to regulatory agencies within required time lines. The person will drive the clarification of complaints including distributors to ensure they are correctly prioritised, and interact with health care providers and regulatory agencies to ensure all questions are addressed within established time-frames.
Other responsibilities include
- Support to product managers throughout the life cycle of the product in regulatory terms to ensure product compliance with medical device requirements
- Definition of safety measures (FSCA), active participation in product recalls and recall communications to markets and health authorities
- Involvement in internal and external audits and the audit responses
- Process improvement wrt Vigilance reporting
Above all this position requires a solid knowledge of complaints handling processes and vigilance reporting within the medical devices industry. While the actual complaints will be addressed by SMEs on site, some technical know how or background would be useful for this role as the products are electro-mechanical in nature.
We are aiming for mid April interviews so please apply now
For more information on this vacancy, or any other QA opportunities within the Swiss Medical Devices sector, please contact the Senior Consultant Andrew Boroky on 0041 43 50 80 816, or email him at email@example.com together with scanned certifications of training and Arbeits Zeugnisse.
For industry news and new opportunities in QA within the Medical Devices and Diagnostics sectors, please join my Linked group at ch.linkedin.com/in/qaswitzerland/en
KEY WORDS: Vigilance, adverse event, incident, post market surveillance, Complaints, Switzerland, Quality Assurance, Compliance, CAPA, Medical Devices, German, English, 21 CFR 820, MDR, MDD, ISO 13485 / IEC 60601, product recalls, FSCA, audit, regulatory, health authorities, distributor, notified body, Medical Device jobs, Nonstop recruitment, Manufacturing, Engineering
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