Pronova Laboratories develops and registers medical devices for various ailments that are being sold across the world. Pronova is a growing organization located in Muiden, just outside Amsterdam.
We are looking for an RA/QA junior to assist in core processes that allow development and production of the highest quality standards. Together with our QA/RA manager you will bring our medical device registrations to the next level. You can directly impact Pronova’s quality goals, inspiring others around you in the process.
Aim of the position:
- Quality (Assist in) Maintaining and updating Pronova’s quality management system, in compliance with MDD/MDR, ISO 13485:2016 and FDA 21 CFR Part 820.
- Regulatory (Assist in) Composition and submission of product files to relevant authorities and/or Notified Bodies.
Core tasks and responsibilities:
- Executing Complaint Handling, Non-Conformity and CAPA procedures;
- Performing internal and external audits;
- Continuously improving the Quality Management System;
- Updating product portfolio in compliance with the Medical Device Regulation;
- Composition of product files and technical documentation;
- BSc/MSc in pharmaceutical sciences, life sciences or equivalent;
- No more than 2 years experience in a medical device quality/regulatory position;
- Structured and systematic attitude;
- Talent for organisation and planning;
- Excellent verbal and written communication skills in both Dutch and English;
- Knowledge of ISO 13485:2016, 21 CFR Part 820 and MDD 93/42/EEC;
- Knowledge of Risk Management (ISO 14971:2012), Clinical Evaluations (MEDDEV 2.7.1 rev 4) and Clinical Investigations (ISO 14155:2011);
- Knowledge of MDR EU 2017/745 and FDA 510(k) procedures.
Are you interested and do you fulfil the requirements? Please send your resume and a detailed motivation letter in English to email@example.com. If eligible, you may expect an invitation for an interview within one month.
Questions about this vacancy?
Please contact Pronova Laboratories at +31 (0) 29 4466611.