Regulatory Affairs and Quality Assurance Manager

vor 4 Wochen


BielBienne, Schweiz Guided Solutions Vollzeit

For our client, we are looking for an experienced Regulatory Affairs and Quality Assurance Manager to join their growing team.

The company is an early-stage, pre-revenue start-up, looking to make its first 510k submission of a complex electro-mechanical device incorporating advanced software.

The main responsibilities of the role are both RA and QA initiatives and it is important you are prepared to manage both. The role is highly operational, though you will build a team during the next 24 months. The experience of US FDA submissions is essential.

Please note the role requires a daily commute to the office.

**Key requirements**:

- Relevant University degree.
- A proven track record of successful FDA/510k submissions is essential.
- Excellent knowledge of the medical device industry and regulations, including ISO 13485, for complex devices.
- Experience in a fast-paced and cross-functional environment.
- Excellent communication skills.
- Attention to detail and self-organised person.
- English language is a must.
- Ability to be in the office daily.



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