Location: Winnersh

Industry: Medical Devices

Job Title: Senior Regulatory Affairs Specialist  

Job Type: Permanent – Hybrid

Salary: Up to £45k + bonus

We are a market leading Medical Device company, who, due to our exceptional continued growth, have an exciting opportunity for a Senior Regulatory Affairs Specialist to join our highly motivated team.

As our new Regulatory Affairs Specialist, you will be responsible for the maintaining the development, manufacturing and life cycle of active Medical Devices to meet regulatory requirements and technical standards.

For our new Regulatory Affairs Specialist to be successful, you will be an enthusiastic member of the team, participating with ownership in a fast-evolving environment. You will have a strong knowledge and experience of international regulations and standards within Medical Devices.

This is an excellent opportunity for a committed individual who is looking to join a progressive and innovative company with a passion for helping you to develop.

EDUCATION/EXPERIENCE

• Proven experience in Regulatory Affairs in Medical Devices
• Strong working knowledge of Risk Management, Software Life Cycle, Design Control and V&V processes
• Experience in CE Marking in compliance with MDR/MDD
• Strong knowledge and experience of International Registrations and Approval processes for Medical Devices
• Strong communication and influencing skills

If you have the necessary skills and experience to be successful in this role, please click “Apply Now” or contact Chloe Halls on 01189 239 233 to discuss further.