Regulatory Affairs Officer

For a dynamic Medical Device organisation specialized in state-of-the-art surgical devices, I am looking for a Regulatory Affairs Officer.
Because of constant growth, expansion of the RA team is currently needed where one of the focus points of the position is on execution and maintenance of worldwide product registations. This concerns a varied position in which you work closely with the Quality Assurance team.

 

MAIN RESPONSIBILITIES

• Start worldwide registrations of current and new products
• Compose Registrations dossiers, perform checks and maintain registrations
• Make inventory of the relevant regulations of new products
• Monitor, assess, maintain and optimise internal processes
• Maintain contact with distributors and authorities (governments, Notified Bodies and other authorities).

 

YOUR PROFILE

• Minimum of a Bachelor’s degree in a relevant area
• Experience with Regulatory Affairs in Medical Devices (ISO 13485)
• MDR knowledge is a preference
• Good communication in English. Chinese is a plus
• Quality conscious, communicative, precise, analytical, proactive, solution-minded.

 

ORGANISATION & OFFER

You will work in a fast-growing organisation with a down-to-earth, informal culture with short lines of communication.

A unique opportunity to have a fast-track development in the Medical Device organisation. The company offers the possibilities to grow within the organisation and it is possible to follow training courses.

You can expect a competitive offer including a competitive salary and attractive conditions.
 

INTERESTED? Reach out to Christian Steenkamp for more information by contacting +31 (0)20 20 44 502 or c.steenkamp@panda-int.com