For our partner, I am looking for a Global Safety Vigilance Manager (Medical Devices, QA) 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 be responsible for maintaining the QMS related to safety and optimizing the Medical Device procedures. Next to that, you’ll work closely with the Head Safety Vigilance to ensure that all vigilance operations are compliant with the standards.
- Lead EU local medical device projects/work streams and task forces
- Provide opinion to the processes, policies and procedures of vigilance
- Prepare and maintain a medical device vigilance agreement in collaboration with QA
- Creation, review, maintenance, and update of uniform global safety SOPs
- Provide safety vigilance trainings to employees
- Bachelor’s degree (or equivalent), preferably in Pharmaceutical area or Life Sciences
- At least 3 years’ experience in Safety Vigilance of Medical Devices
- Familiar with medical device regulations relating to safety vigilance, especially MDR
- Ability to interact effectively in a multifunctional and multicultural team setting
- 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