Regulatory Officer

With over 35 years of experience, Flexicare is a leading designer and global provider of medical devices that enhance patient care. Headquartered in the UK, we support clinicians worldwide with class-leading devices and a global network of subsidiaries across over 100 countries. Flexicare has ambitious plans for international growth and we want you to be a part of our journey!

What You'll Do

Based in our HQ in Mountain Ash, you will form part of our growing global Regulatory Team, taking ownership of product registration and associated activities within key registration jurisdictions.

• Contribute to the creation of labels for NPNI including UDI GS1 allocation.
• Support the control of Revisions to Declaration of Conformity
• Contribute on the update and maintain of external regulatory portals (MHRA, FURLS, EUDAMED)
• Contribute on the update an maintenance of internal regulatory databases
• Contribute to Non-priority
  
  EU MDR TFs completion project; contribute with DDE/risk management/GSPR/Label/IFU/TF summary
• Lead on the resolution of regulatory compliance matters of devices cleared in the field (CFS, tender applications).
• Contribute to gap analysis of standards
• Liaise with all departments to support Regulatory department activities

Who You Are

We believe you're the right fit if you have

• Degree (or equivalent) in a scientific or engineering field
• Minimum 1 years' experience as a Regulatory Affairs professional in Medical Devices.
• Particular knowledge of regulatory requirements for medical devices including Medical Device Regulation (MDR) 2017/745 & UK MDR 2002 Part II and. ISO 13485 and ISO 14971.
• Strong collaborative skills- a confident and clear communicator with the ability to inform and influence diverse stakeholder groups
• Proficient in various software packages including but not limited to Microsoft Word, Excel, Power Point and Adobe.

What You Will Get

• Competitive Salary in accordance with experience and capabilities
• Pension
• Annual Company performance bonus
• Benefits package:
  Life Assurance (2 x salary), Income Protection (50% Salary), Health Cashplan, Monthly Benefit Fund - use towards other benefits or add to your pension pot
• Balanced Working - 1 day working from home per week

Applications close on Friday 13th February 2026