Regulatory Affairs Specialist

2 weeks ago


Cardiff, Cardiff, United Kingdom Hunter Selection Full time

Job Overview

At Hunter Selection, we are seeking an experienced Regulatory Affairs professional to join our team. As a Senior Regulatory Specialist, you will play a key role in designing and implementing Quality Management Systems for design control, ensuring continuous compliance with regulatory requirements.

Responsibilities

  • Develop and implement regulatory strategies for new product development and existing products to maintain compliance with international regulatory standards.
  • Prepare and submit regulatory applications to international regulatory approvals, ensuring timely and accurate compliance.
  • Lead RA activities and serve as the first point of contact for compliance enquiries, providing expert guidance and support.
  • Manage day-to-day activities and tasks, working independently in RA matters to ensure seamless operations.

Requirements

  • Medical Device experience is essential for this role, with a proven track record of regulatory compliance and submission.
  • Class 2A/B medical device experience is required, with a strong understanding of regulatory application knowledge.

What We Offer

  • Highly competitive salary and bonus opportunity.
  • 25 days + bank holidays, employee assistance program, and matched 5% pension.
  • Funded company social events, free on-site parking, and secure cycle shelter.
  • Discounts at local restaurants and gyms.

About Us

Hunter Selection is a recruitment consultancy with UK-wide offices, specialising in permanent and contract roles within Engineering & Manufacturing, IT & Digital, Science & Technology, and Service & Sales sectors.

We are proud to support a rapidly growing organisation with exciting plans to increase headcount on site due to increased market share and orders.



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