At this moment, I am looking for a RA/QA Specialist (MDR) 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 be involved in the MDR project, wherein you’ll frame/ plan the execution of the MDR compliance processes together with the QA Manager. Next to that, you’ll be active with Risk Management, Project Management and support QA activities like maintaining the QMS.
- Ensure that MDR is implemented and maintained in EMEA and defined within the projects in partnership with countries and (external) stakeholders
- Manage and communicate progress of MDR projects and coordinate activities with departments like RA, Manufacturing, etc.
- Develop, maintain and share appropriate documentation of processes and methods
- Ensure establishment of all necessary infrastructure for MDR compliance and implementation
- MDR and ISO 13485 compliance of project activities
- Support Medical Device QA activities like maintaining the QMS.
- Bachelor or higher degree (or equivalent) in a relevant area like Life Sciences or Engineering
- At least 3 years’ experience in QA/RA of Medical Device or Pharma (MDD/ MDR/ ISO13485)
- Proven experience in Project Management
- Excellent English verbal and written skills
- Pro-active, strong communicator, open and transparent, self-starter 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. Our 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