Quality & Regulatory Manager

6 maanden geleden

Ede, Nederland AMT Medical Research BV Voltijd

AMT Medical Research is a small, dynamic company where you will help to change the life of more than a million heart patients per year. AMT is a medical device company that develops innovative technologies for Coronary Artery Bypass Surgery (CABG). Our head office is in Ede (The Netherlands), with research facilities at the Utrecht Science Park. To expand our quality team we are looking for a:
**Quality & Regulatory Manager**

**Responsibilities**:

- As a Quality Assurance and Regulatory Affairs Manager, you support the Director Quality and Regulatory on all activities regarding the Quality Management System (QMS), Quality Assurance (QA) and Regulatory Affairs (RA).
- Support the supervision of the required QA/RA processes and maintain quality and regulatory awareness at all relevant AMT functions.
- Develop and maintain QMS compliance and maintain the quality system policy by complying with ISO 13485:2016, 21CFR 820, Medical Device Regulation (MDR) 2017/745 and other applicable legislation, (product) standards and guidelines.
- Have first line responsibility in setting up, guiding and (co)-creating regulatory documentation for certification and approval of the medical devices manufactured by AMT.
- Prepare the regulatory submissions in close cooperation with the Director Q&R and other stakeholders.
- Maintain an up-to-date knowledge level of international medical device regulations and for AMT Medical applicable (product) standards.

**Qualification and educational requirements**:

- Relevant Bachelor’s or Master’s degree, preferably in life science or technical related topic.
- At least 5-7 years of experience in a QA/RA position in a medical device company.
- Knowledge of ISO 13485, 21 CFR 820, MDR, as well as relevant (product) standards/regulations.
- Experience with medical device packaging, sterilization, and aging processes.
- Experience with MDR technical file submissions, registrations and/or FDA approvals.
- ISO13485 auditor, preferably lead auditor.

**Preferred skills**:

- Proficient in spoken and written Dutch and English
- Ability to write Quality and Technical Documentation
- Effective interpersonal communication skills - both written and oral
- Accurate, detail oriented and able to see the big picture
- Result driven, willing to take that extra step
- Ability to work independently and be self-motivated

**Additional information**:

- You will be based in Ede
- We offer a market conform salary
- Possibility to grow to a leading role in QA or RA.
- You become part of an enthusiastic team

AMT Medical Research BV
Attn Harry Teirlinck

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