For our partner, I am looking for a Regulatory Affairs Lead that fits the spirit of a well-established global Medical Devices & Pharmaceuticals company aiming to accommodate new and evolving initiatives in ophthalmology. This company is in an exciting phase of growth with a market leading portfolio.
In this role you’ll actively support CE Marking for Medical Devices, maintain contact with Authorities and support the Regulatory strategy for among others the development of new devices.
- Maintain and establish Technical Documentation for CE Marking
- Provide regulatory support for development of Medical Devices both regional and global
- Support regulatory preparation to Notified Body audits
- Provide support for clinical trials
- Maintenance of the regulatory database
- Follow-up on new trends and regulations in the Europe region
- Master’s degree (or equivalent) in Pharmaceutical area or Life Sciences
- At least 3 years’ experience in RA of Medical Devices
- Familiar with ISO13485, MDD/ MDR and CE Marking
- Excellent English verbal and written skills
- Pro-active, independent and driven
ORGANISATION AND OFFER
With 100+ years of investigative insight, the company remains committed to the discovery, exploration, and development of ophthalmic therapies. Now, and into the future. Their clinical development network now spans three continents, with centers in EMEA, Japan, and the US.
The organisation offers a competitive salary and benefits.
INTERESTED? Reach out to Christian Steenkamp for more information by contacting +31 (0)20 20 44 502 or firstname.lastname@example.org