Regulatory Affairs Specialist

Job Reference: #61821 Add to saved jobs

  • Salary £35000
  • Location South Wales
  • Permanent
  • Sector Medical Devices

Job Summary

My client is seeking a Regulatory Affairs Specialist with strong MDD technical file experience, who is looking to progress within a successful medical device business. This company are one of the UK’s leading supplier of medical devices and pharmaceutical products to the primary and secondary care markets. The wider business group are continuing to grow through acquisitions, developing their product portfolio further, so there is a great opportunity to get exposure to a wide-range of devices.

Job Overview

• To provide operational technical support for the Head of Regulatory Affairs in particular regarding medical device regulatory affairs at both company and group level.
• Efficient administration and management of regulatory Technical files to maintain CE Marking.
• To develop and deliver strategy to meet the requirements of the new Medical Device and IVD Regulations.
• To act as ISO Quality system representative to ensure compliance with ISO 13485 & ISO 9001 systems in conjunction with QEHS Department.
• To provide a high level of customer service as first point of contact/key interface with externals on technical queries, complaints, recalls/FSCA, vigilance incl post-marketing surveillance and quality issues for medical devices and pharmaceuticals.

Skills Required

• Regulatory experience in Medical Devices including technical file management
• Experience of working in an ISO 9001:2015 environment and ISO 13485:2016
• Experience of regulatory body liaison e.g. the MHRA/HPRA/FDA
• Proven ability to work as part of a multi-functional team

Contact Details

Please contact Nathan Berkley on 0203 019 6020 or email if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.

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