Regulatory Affairs Specialist Medical Devices

In order to supports its activities with Medical Devices, Christeyns is seeking a Regulatory Affairs Specialist for Medical Devices.

You will:

• Collaborate in a multi-disciplinary team with Regulatory, Quality, Technical, Marketing, R&D and Production in order to assure compliance with the Medical Devices Regulation.
• Communicate with the Notified Body for organization audits (re-certification every 5 years and annual follow-up audits) and lead these audits.
• Organize and coordinate post-market follow-up studies in collaboration with local sales companies
• Prepare, update and submit technical dossiers of medical devices.
• Be responsible for reporting incidents with Medical Devices.
• Cooperate with consultants and laboratories for the generation of tests required for the medical devices registration.
• Keep informed about Medical Devices legislation and guidance.

You are part of the Corporate Regulatory Affairs team and you will be based in Belgium. You will report to the Regulatory Affairs Manager.

Required:

• You have a higher education with knowledge of chemistry (Master).
• You are communicative and open-minded, a team player.
• You have good writing skills.
• Fluent speaking and writing in English is a must.

We offer:

• The chance to work in a successful and stable company.
• A job in a company, family owned, combining the informal culture of a local business with the position of an international top player.
• Development possibilities for ambitious and driven employees. All necessary training and support to perform the job will be offered where required.
• A sound remuneration that grows with the evolution of the company, offering besides a fixed gross salary also an insurance package.