For a fast-growing medical device organisation, I am currently looking for a RAQA Director. In this role, you are responsible for leading the RA/QA team within the organisation, to assure compliance to international quality and regulatory requirements for Medical Devices and Pharma.
· Development and implementation of a strong and effective RA/QA strategy;
· Product submissions/approvals, license renewals, periodic updates and product company registrations to regulatory agencies;
· Fulfil role of Management Representative;
· Documented QMS;
· Change Management, Risk Management, Deviation & CAPA Management, Complaint Management, Post Market Surveillance and Quality auditing;
· Will be the first contact person for all QA/RA matters.
· Strong background RA and QA for Class II or III Medical Devices.
· Experience with Notified Bodies like FDA;
· Can stimulate the development of the members in the team to effectively execute the RA/QA activities;
· Excellent communication in Dutch and English.
ORGANISATION AND OFFER
For more than 50 years, this organisation is specialised in innovative medical devices. They are refining technologies that are game changing in the field and this organisation is unique in what they do. The organisation offers an attractive salary and generous conditions.
INTERESTED? For further information, contact Christian Steenkamp at +31 (0)20 20 44 502 or by email at email@example.com