We offer a job as a Regulatory Consultant – Medical Devices, in which you will:
- optimally combine your scientific background and regulatory knowledge
- work in an international environment of pharmaceutical and medical device/in vitro diagnostics industry
- prepare and update technical documentation (eg. STED, BSER, CER, RMP) for applications
- coordinate and manage authorisation procedures and interactions with notified bodies
- implement and maintain ISO 13485 QMS
- act as authorized representative
- perform medical device directive vs. regulation gap analysis
- be coached by Zwiers
- live up to the Zwiers “professional approach with a personal touch” spirit
- an MSc/PhD in Pharmacy, Medical Biology, Chemistry, Life Sciences
- 2-3 years of experience in the medical device/IVD industry, preferable RA/QA
- Knowledge of ISO standards; audit experience is a plus
- eager to learn, develop and excel
- flexible and pragmatic
- the ability to handle stringent deadlines
- writing and editing skills (English)
- the ability to communicate in a convincing way
Zwiers Regulatory Consultancy offers a fulltime job, but is willing to discuss a part time contract. Salary will depend on education, knowledge and experience.
For further information you can contact Alex Zwiers, CEO, at tel. +31 (0) 610489150.
We look forward to your application. You can apply via email: firstname.lastname@example.org.