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Regulatory Affairs Specialist

2 months ago

Cardiff, Cardiff, United Kingdom Hunter Selection Full time
Senior Regulatory Specialist

Cardiff, UK

Commutable from surrounding areas

Job Summary

We are seeking an experienced Regulatory Affairs professional to join our team in Cardiff. As a Senior Regulatory Specialist, you will be responsible for ensuring the compliance of our medical devices with regulatory requirements.

Key Responsibilities
  • Lead RA activities and be the first point of contact for compliance enquiries
  • Develop and implement regulatory strategy for NPD and existing products to maintain compliance
  • Submission of regulatory applications and communications with international regulatory approvals
  • Preparation of submissions and communication with regulatory organisations
Requirements
  • Medical Device experience is essential for this role
  • Class 2A/B medical device experience
  • Good regulatory application knowledge
What We Offer

We offer a highly competitive salary, bonus opportunity, and a range of benefits including 25 days + Bank Holidays, employee assistance programme, matched 5% pension, and funded company social events.

If you are an experienced Regulatory Affairs professional looking for a new challenge, please contact us for a confidential discussion.