We now have a vacancy for a (junior) Regulatory Affairs Officer (part-time 24 hours per week) with a background in molecular biology. Experience in regulatory affairs, performance evaluation in the IVD sector, ISO and quality assurance, is preferred. You will be involved in preparing and updating technical files for ISO 13485 and IVDR, and executing transition from the IVDD to the IVDR. This position is a great opportunity to apply your expertise and continue to build your knowledge.
Your role and responsibilities:
- IVDD to IVDR transition for commercial registration of Self-screen’s assay portfolio;
- Registration of assays with regulatory partners;
- Filing, updating and communication with Notified Bodies;
- Collaboration with R&D scientific team upon new or extended claims;
- Quality assurance;
- Certification and audits;
- Regulatory affairs;
- Supporting clinical studies and assay development performed by the R&D Department.
And this is what you will bring:
- A technical or scientific degree (MSc or PhD) in molecular biology.
- Preferable at least one year working experience specifically in IVDs through positions in industry, consultancy or regulatory agencies (Notified Bodies,) in either manufacturing, R&D, quality or regulatory roles. Candidates with no specific experience but passionate about regulatory affairs and in vitro diagnostics, are also invited to apply. Self-screen has highly experienced external consultants for support of the Regulatory Affairs Officer to gain knowledge and experience.
- Good knowledge of IVD regulations or willing to develop this knowledge.
- Experience with ISO 13485 quality systems; audit experience is an advantage but not essential.
- Ability to manage and monitor moderately complex projects in close cooperation with our dedicated R&D team.
- Project management skills.
- Fluency in Dutch and English.
For more information contact Wim Ket +31 (0)6 11 922 820.
Getting excited about a career at Self-screen in the dynamic and innovating world of in-vitro diagnostics? Please send your resume and letter of motivation to firstname.lastname@example.org