Regulatory Affairs Specialist in Medical Devices

7 days 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, a leading recruitment consultancy. As a Senior Regulatory Specialist, you will play a key role in ensuring the compliance of our medical devices with regulatory requirements.

Key Responsibilities
  • Participate in New Product Development (NPD) team and remediation activities to prepare and maintain technical files for continuous compliance.
  • Prepare and submit regulatory applications and communicate with international regulatory organizations.
  • Develop and implement regulatory strategies for NPD and existing products to maintain compliance.
  • Lead RA activities and serve as the first point of contact for compliance inquiries.
Requirements
  • Class 2A/B medical device experience is essential for this role.
  • Good knowledge of regulatory applications and procedures.
  • Ability to lead RA activities and communicate effectively with cross-functional teams.
What We Offer
  • A competitive salary and bonus opportunity.
  • A comprehensive benefits package, including a matched 5% pension and employee assistance program.
  • Opportunities for professional growth and development in a rapidly growing organization.


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