Regulatory Affairs Officer

Job details

Regulatory Affairs Officer: This expert global company is looking for a Regulatory Affairs Officer to join their Oxfordshire based team. The Regulatory Affairs Officer will take an important role from the outset, quickly establishing themselves as a key member of the regulatory team.

Regulatory Affairs Officer - key responsibilities:

• Prepare regulatory submissions for worldwide product registration
• Preparation and maintenance of technical files in accordance with the IVD Directive and Medical Devices Directive
• Supporting the introduction of new products through the new product design and development process
• Create and maintain product registration/shipping database
• Maintain product Design History files

Regulatory Affairs Officer - qualifications, skills and experience:

• Comprehensive experience within the IVD, medical devices or pharmaceutical industry in a quality or regulatory role
• Working knowledge of FDA QSR (21 CFR 820) and ISO13485:2003
• Exceptional interpersonal / communication skills with the ability to liaise with professionals at all levels
• Enthusiastic and positive attitude

Regulatory Affairs Officer: This is an outstanding opportunity for a dedicated Regulatory Affairs Officer to join a quality Oxfordshire based company.