For an international medical devices company, we are looking for a junior Regulatory & Quality officer. This is a full-time role, starting asap and for a minimum period of 6 months (can be prolonged).
What is your job?
1. Ensure compliance of products
– Ensure follow-up complaints Processing processes related to product quality with Benelux production units including materiovigilance, recalls and FSCA activities etc.
– Ensure training of medical representatives on Medical Vigilance
– Ensure providing of requested documents such as declarations of conformity, CE certificates and user manuals
– Ensure preparation of KPI’s
– Ensure participation in tenders and providing RAQ related information
– Ensure follow-up on corrective actions in response to the event of a CAPA, non-conformance and/or observations during the quality audit
– Ensure the submitting of RECUPEL, Val-i-Pac etc.
– Prepare and follow-up purchase orders within the Ariba / Esker system
– Ensure booking of travel and accommodation
– Organize trainings and prepare training materials
2. Ensure regulatory and normative surveillance in connection with Benelux medical device regulations
– Ensure regulatory and normative surveillance in connection with Benelux medical device regulations
– Provide relevant internal local about the regulations in the Benelux regarding medical devices
3. Quality Management system within the company
– Support Maintenance of the Quality Management system and (re)certify certification according to ISO (ISO 9001- ISO 13485)
– Participate in group audits (RA / QA / HSE)
Who is the candidate we are looking for?
You have a Bachelor/master’s degree in sciences and preferably a first experience in Regulatory affairs.
Knowledge of the regulations regarding medical devices
Knowledge of Material Vigilance
Microsoft Office, knowledge of traceability and complaints treatment systems desirable eg.SAP, Pilgrim
Punctuality / Strictness
Good priority management
Insight into organization & planning
Analytical & synthetic spirit
Commitment / communication skills at and with all levels
Editorial and relational qualities
Dutch and English
What is the offer?
A chance to learn and develop in RA/QA affairs within the medical devices industry. This could be a start of a longer career in the company, starting with a contract of 6 months.
Want to take this challenge?
Send your resume to email@example.com /firstname.lastname@example.org and tell us a little more about yourself. We will hear from you soon!