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    1 month ago

    Cardiff, Cardiff, United Kingdom Hunter Selection Full time

    Senior Regulatory SpecialistCardiff, UKCommutable from surrounding areasJob SummaryWe 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 ResponsibilitiesLead RA activities and be...

  • Regulatory Affairs Specialist

    1 month ago

    Cardiff, Cardiff, United Kingdom Hunter Selection Full time

    Senior Regulatory SpecialistCardiff, UKCommutable from surrounding areasJob SummaryWe 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 ResponsibilitiesLead RA activities and be...

Regulatory Affairs Specialist

2 months ago

Cardiff, Cardiff, United Kingdom Hunter Selection Full time
About the Role

We are seeking an experienced Regulatory Affairs professional to join our team at Hunter Selection. As a Senior Regulatory Specialist, you will play a key role in ensuring the compliance of our medical devices with regulatory requirements.

Key Responsibilities
  • Design and implement Quality Management Systems (QMS) for design control
  • Participate in New Product Development (NPD) teams and remediation activities to prepare and maintain technical files for continuous compliance
  • Prepare submissions and communicate with regulatory organizations
  • Develop and implement regulatory strategies for NPD and existing products to maintain compliance
  • Submit regulatory applications and communicate with international regulatory approvals
  • Monitor new standards and ensure NPD meets recognized consensus standards
Requirements
  • Medical Device experience is essential for this role
  • Able to lead RA activities and be the first point of contact for compliance inquiries
  • Able to manage day-to-day activities and tasks, and work independently in RA matters
  • Class 2A/B medical device experience
  • Good regulatory application knowledge
What We Offer

As a Senior Regulatory Specialist at Hunter Selection, you will receive a highly competitive salary, bonus opportunity, 25 days + bank holidays, employee assistance program, matched 5% pension, funded company social events, free on-site parking and secure cycle shelter, and discounts at local restaurants and gyms.