Regulatory Affairs (RA) Specialist (32 hr/wk)
As MRC’s Regulatory Affairs Specialist, you assist in ensuring that MRC Holland and its products meet regulatory requirements for its target markets in a swift manner that is compatible with other MRC objectives. This function requires understanding of the regulatory requirements applicable to In Vitro Diagnostics and Research Use Only products in the target markets. The Regulatory Affairs Specialist assists in the submission of registration files to relevant competent authorities and / or Notified Bodies. Collaborates with QA, Product Development and Technical Support department to achieve departmental goals. You report directly to the RA Manager.
- Assist in the coordination of preparation of registration files for specific target markets for new products, product changes and re-registrations as needed, in compliance with internal procedures and relevant regulatory requirements for the particular jurisdiction.
- Write, edit and maintain elements of technical documentation for regulatory submissions.
- Assess or give final approval to, as appropriate, documents prepared by design team members.
- Act as RA representative in design review meetings.
- Responsible for the quality of RA-related design project deliverables and documentation.
- Stay informed on new developments in relevant (inter-)national legislations and regulations on IVDs and assist in implementation activities.
- Contribute to quality assurance within the department.
- Keep the RA Manager informed on the progress of project activities at all times.
- MSc degree in Biology or Biomedical Sciences.
- Adequate knowledge of relevant international regulations regarding IVDs, and upcoming changes in these (e.g. ISO 13485, European IVD Directive (98/79/EC), European IVD Regulation (EU 2017/746), Chinese FDA, US FDA (21CFR820) and regulations of other countries where MRC Holland places IVD products on the market).
- Adequate knowledge of genetics.
- Advanced technical writing skills in English.
- Well-developed analytical skills.
- Affinity with procedures and systems.
- Strong organizational skills, flexible, ability to manage multiple tasks and meticulous attention to detail.
- Able to work independently as well as part of a team.
What do we have to offer?
MRC Holland is a medium size and flexible organization, with colleagues from different cultural backgrounds where working independently and professionalism are of important values.
Moreover, we have excellent working conditions. At MRC Holland, besides 28 holidays a year, we are closed between Christmas and New Year’s Day. We have an excellent pension plan, a good travel allowance and collective health insurance, with a partial reimbursement from MRC Holland. Finally, we offer a reimbursement of (max.) €25 a month for your sports subscription, and you can participate in weekly in-house yoga class or Dutch lessons.
MRC Holland is a biotechnology company specialised in the production of assays for gene copy number and gene variant detection.
MRC Holland is best known as the producer of Multiplex Ligation-dependent Probe Amplification (MLPA®) assays. MLPA continues to be the gold standard in the field of gene copy number detection, and MRC Holland’s 400 different MLPA assays are used on millions of samples every year.
It is MRC Holland’s mission to manufacture and distribute affordable and reliable genetic tests worldwide. The company’s products are easy to use and implement into research and diagnostic settings, as they run on standard laboratory equipment, use standard platforms and free MRC Holland-developed software for analysis.
With our products you can achieve confidence in copy number determination.
Please send your motivation letter and curriculum vitae before 15 January to apply[@]mrcholland.com. For more information, contact Johanneke Oud (via apply[@]mrcholland.com). Interviews are scheduled in week 4 & 5 of 2020.
Only applicants who are currently residing in the Netherlands and possess a valid working permit will be considered. For more information on our company and products, see http://mrcholland.com.
Acquisitie naar aanleiding van deze advertentie wordt niet op prijs gesteld.
Only direct applications are welcome.