Regulatory Affairs Specialist

2 months ago


Cardiff, Cardiff, United Kingdom Hunter Selection Full time

Job Title: Regulatory Affairs Specialist

We are currently seeking an experienced Regulatory Affairs Specialist to join our rapidly growing organisation. As a key member of our team, you will be responsible for designing and implementing QMS for design control, preparing and maintaining technical files, and ensuring continuous compliance.

Main Responsibilities:

  • Design and implement QMS for design control
  • Prepare and maintain technical files to ensure continuous compliance
  • Prepare regulatory submissions and communicate with regulatory organisations
  • Develop and implement regulatory strategy for NPD and existing products
  • Submit regulatory applications and communicate with international regulatory approvals

Requirements:

  • Medical Device experience is an essential requirement for this role
  • Able to lead RA activities and be the first point of contact for compliance enquiries
  • Able to manage day-to-day activities and tasks, and work independently in RA matters

About Us:

Hunter Selection is a recruitment consultancy with offices across the UK, specialising in permanent and contract roles within Engineering and Manufacturing, IT and Digital, Science and Technology, and Service and Sales sectors. We are committed to providing exceptional service and supporting our clients in finding the best talent for their business.

We Offer:

  • A highly competitive salary
  • A bonus opportunity
  • 25 days + bank holidays
  • An employee assistance programme
  • A matched 5% pension
  • Funded company social events
  • Free on-site parking and secure cycle shelter
  • Discounts at local restaurants and gyms

How to Apply:

If you are interested in this role, please click 'apply' to submit your application. We look forward to hearing from you



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