Regulatory Affairs and Quality Deputy Director
hace 2 semanas
iLine Microsystems is currently in a consolidated phase of growth and expansion and therefore needs to incorporate a person in the Quality Department.
Reporting directly to the Regulatory Affairs and Quality Director, this position is integrated in a multidisciplinary department and it has the following responsibilities and tasks:
- To actively participate in the development and implementation of regulatory strategies in strategic projects (FDA, new developments, etc.).
- Coordinate the implementation of processes and documentation according to ISO 13485, 21 CFR Part 820 and 21 CFR Part 11 as well as other regulations (e.g. REACH, RoHS, etc.).
- Coordinate product registration in other countries.
- Coordinate product design and development activities.
- Coordinate process validation activities (including software).
- To audit suppliers and subcontracted companies.
- Take part in internal and third-party audits.
The ideal profile for the vacancy is a professional with a degree in Health Sciences (Pharmacy, Biology, Chemistry or Biomedical Engineering) with at least 3 years of experience in a similar position.
It is essential to have a high English level.
Knowledge or experience in the following topics will be highly appreciated:
- Regulatory; ISO 13485.
- Knowledge in IVD Medical Device Regulations (European, FDA and other international regulations).
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