Regulatory Affairs (RA) specialist (32-40h/wk)
Regulatory Affairs (RA) Specialist (32-40h/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.
- 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.
- MSc degree in Biology, Biomedical Sciences or equivalent.
- 1-3 years of relevant working experience
- Adequate knowledge of relevant international regulations regarding IVDs (e.g. ISO 13485, European IVD Regulation (EU 2017/746)).
- 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 alone as well as part of a team.
What do we have to offer?
We offer a great position in a medium-sized, flexible organization, where many people from different cultural backgrounds work, and where independence and professionalism are of paramount importance. Starting salary: €3894-€4673. In addition, we have excellent employment conditions. At MRC Holland we have 28 holidays a year and are also closed between Christmas and New Year's Day. We have full reimbursement for travelling with public transport, an excellent pension scheme and extensive collective health insurance with reimbursement from MRC Holland. Finally, you will receive a reimbursement of max. €25 per month on your sports subscription, and you can participate in yoga classes or chair massage.
Please send your cover letter and curriculum vitae to email@example.com. The same email address can be used for any questions.
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 www.mrcholland.com.
Only direct applications are welcome.