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The companyOur client is a professional Medical Devices organization, based in Gelderland Netherlands. is an innovative company which is developing a revolutionairy new surgical medical device. The development is almost finalized and the market introduction is only a few months away
Role descriptionDue to the temporary leave of the current QA/RA Manager, the position of Quality Assurance and Regulatory Affairs is open for a period of 4 months. Your role involves the setting up of a QMS according to ISO13485 and FDA CFR 820. You will be the centre of the Quality related items, and your sparring partner will be the chief of development. You will also be involved in the ongoing development and improvement of the device.
This generalist function will also contain regulatory activities. As mentioned the medical device is weeks away from market introduction, so the company is focussing on obtaining a CE-mark and in a later stadium also the 510(k) approval.
The role is focussing on pre-market Quality and Regulatory Medical Devices.
Responsibilities- Setting up compliant QMS according ISO13485 - FDA CFR 820
- Formulating SOP and working instructions
- Being the Lead regarding the compliance for EC, UL, FDA
- Experience with DEKRA is a pre
Requirements- Technical, Medical, Engineering Bachelor
- Experience in QA Medical Devices - class 2/3
- In depth knowledge in QMS and compliance systems
- Good experience in verification and validation of Medical Devices
- Good documentation experience
- Fluent in English
- Experience with Notified Bodies