Technical Documentation Writer – In Vitro Diagnostics (32-40 hrs/wk)

As a Technical Documentation Writer in the In Vitro Diagnostics (IVD) Development Department, you will be responsible for the annual update and maintenance of the technical documentation of MRC Holland’s IVD products, in order to meet the regulatory requirements in our target markets. You will work in accordance with standard operating procedures (SOPs), collaborate in cross-functional projects involving several of MRC’s departments, and ensure that work is carried out within schedule. Do you have an MSc (or will soon obtain it) in Biology, Biomedical Sciences or equivalent, affinity with medical/technical writing, and an interest to work with high quality genetic tools for diagnostic purposes? Then we are looking for you!

Responsibilities

The Technical Documentation Writer will be responsible to review and evaluate the safety and performance of the current CE marked MLPA products by conducting annual post-market performance evaluations. This includes:

• Compiling, maintaining and improving the technical documentation required to be in compliance with the Regulation (EU) 2017/746 (IVDR) and other regulations, by:
  • Performing detailed product-specific review based on experimental data, quality testing and novel scientific knowledge.
  • Compiling in-depth information on the scientific validity, analytical performance, clinical performance, and of similar products on the market, by performing literature reviews.
  • Writing and improving the technical documents that describe the product’s safety and performance.
  • Performing product risk analyses.
  • Writing instructions for use.  
• Chairing meetings to discuss the performance of the MLPA product.
• Collaborating on cross-functional projects with the Regulatory Affairs, Quality Assurance, Technical Support and Product Development departments.
• Contributing to the improvement of the post-market performance evaluation process.

Qualifications

• MSc degree in Biology, Biomedical Sciences or equivalent;
• Knowledge on genetics and molecular biology.

Competencies

• Previous experience and/or affinity with medical/technical writing.
• Developed analytical skills.
• Ability to complete work within agreed schedules and manage multiple projects simultaneously.
• Highly motivated, accurate and delivering work of good quality.
• Able to work independently as well as part of a team.
• Advanced writing and communication skills in English.

What do we 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: €3074-€3495 gross per month. In addition, we have excellent employment conditions. At MRC Holland we have 28 vacation days a year and we 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 partial reimbursement from MRC Holland. Finally, you will receive a reimbursement of max. €25 per month on your sports subscription, and you can participate weekly in one of our in-house yoga classes or Dutch classes.

Interested?

Please send your cover letter and curriculum vitae by email to apply@mrcholland.com. The same email address can be used for any questions. A written assessment will be part of the selection process. For more information on our company and products, see www.mrcholland.com.

Only direct applications are welcome.