At this moment, I am looking for a QA/RA Lead that fits the spirit of a well-established global Medical Devices company aiming to accommodate new and evolving initiatives in ophthalmology.
In this role, you’ll lead and ensure medical device projects are implemented and maintained in the EMEA region together with other countries and stakeholders. Next to that, you’ll ensure MDR and ISO13485 compliance and support Quality across the EMEA.
- Develop, lead and drive progress of the MDR project
- Ensure MDR and ISO 13485 compliance of project and quality operational activities
- Contribute to the continuous improvement of QMS
- Be responsible for ISO13485 certification maintenance as importer and distributor
- Conduct quality operational tasks in EMEA like CAPA, deviations, complaint handling, etc.
- Support and participate during the audit by the notified bodies
- Bachelor or higher degree (or equivalent) in Life Science or Engineering area
- At least 3 years’ experience in a Quality/Regulatory role
- Familiar with ISO13485 and MDR
- Excellent English verbal and written skills
- Self-starter, strong communicator, open and transparent, flexible and pragmatic
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 organization offers a competitive salary and benefits.
INTERESTED? Reach out to Christian Steenkamp for more information by contacting +31 (0)20 20 44 502 or email@example.com