Circa €72,000 per annum (depending on experience)
A Japanese Global manufacturing company is looking for Regulatory Affairs, who will be responsible for regulatory compliance with European In Vitro Diagnostic Regulation (IVDR) in European Representative.
Duties and Responsibilities
- Confirm the regulatory compliance of products introduced to European market.
- Perform the obligations as a point of contact with European Committee for post-marketing surveillance and vigilance.
- Cooperate with people involved in the post-market surveillance under the IVDR.
- Provide Product Development Teams with guidance and interpretation of IVDR requirements for the design and development of new products. Recommend and implement compliance strategies for existing, new, and proposed products or product changes.
- Coordinate the requests for performance evaluation or clinical trial of new products in Europe.
- Communicate as a member of cross functional project team during the design, development and regulatory submission process.
- Act as the main point of contact between their companies for new product development and changes to existing products.
· a. Work closely with regulatory affairs and quality team in Japan to establish the robust regulatory/quality system that comply with IVDR.
b. Work closely with Design and Development teams in Japan to ensure the implementation of requirements from IVDR.
c. Assist and Coordinate the product performance evaluation or clinical trial in Europe
Knowledge and Skills
- Bachelors/Masters Degree or equivalent combination of qualifications in chemistry, biology, or other related fields.
- English business level or above.
- Minimum of 3 years experience in European In Vitro Diagnostic Directive (IVDD) for Class A, B and Class C products such as laboratory and Point of Care IVD instrument and reagent, preferably experience with Class D products.
- Proven experience with ISO, GMP/QSR, and other regulatory issues related to medical devices.
- Minimum of 3 years experience in Regulatory Affairs or Quality Systems for medical products manufacturing, preferably medical diagnostics or devices.
- Proven proactive managerial, team-based skills.
- Notable technical writing skills; ability to grasp and communicate strategic issues as well as tactical ones.
- Computer skills such as Word, Excel, Power Point, Project.
AT Amstelbeen, the Netherlands
Candidate must be eligible to work in Holland without any restrictions as no visa support given