Senior Quality & Regulatory Affairs Specialist
Posted on Mar 23, 2020 by Source Technology
Senior Quality and Regulatory Affairs Specialist - CHF 90,000 - 120,000
Early stage Medtech business
As part of the companies growth, this very exciting med tech company based in the centre of Zürich is seeking an experienced Regulatory & Quality professional to join their team.
The company has already launched the product across the EMEA region, and as part of this role you will be responsible for ensuring regulatory approval is maintained across the EMEA, as well as planning entry to the US market via FDA 510(k) submission, as well as managing the QMS to ISO 13485 & QSR standards.
My client expect to almost double in size over the next 12-18 months, so this is the best time to join a company with huge opportunity to grow and develop, whilst working in a great environment where they champion flexible working and really care about employee wellness.
- Work with key stake holders across the business to ensure compliance to relevant regulations for the European, US and Chinese markets
- Manage the preparation and creation of regulatory submissions and registrations for the above mentioned regions
- Help manage and implement change management of technical documents in accordance with the MDR
- Implement a risk management process across the business in compliance to ISO 14971
- Maintain the QMS approval and accreditation to ISO 13485:2016 by liaising with Notified Body to ensure requirements are hit
- Take ownership of CAPA and NCR's for the company, liaising with other departments to ensure all actions are closed out and complete
- At least 3 years' experience in a regulatory & quality role within a medical device company
- Will have led submissions and registrations across Europe, the US and Asian markets
- Ideally will have a track record of creating and authoring technical documentation used as part of a successful submissions (CE Mark & 510(k)
- German and English language is essential
- Will understand the development process and clinical trials for medical device products, as this is a highly development focussed business
This company is looking to exact a real change in this incredibly high growth sector, with a strong track record of results already, it presents a great chance to be part of something big.
If you have a passion for new medical technology, and want to help an amazing business get their products into new markets whilst ensuring its complete safety and efficacy, APPLY NOW!
Send your CV or call for a discussion about the role.
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