Regulatory Affairs Specialist

3 weeks ago


Neath, Neath Port Talbot, United Kingdom Hunter Selection Full time
Regulatory Affairs Consultant

Join a leading medical device business as a Regulatory Affairs Consultant and take on a challenging role that requires expertise in regulatory affairs and quality assurance. As a key member of the team, you will be responsible for ensuring compliance with industry regulations and standards, developing and implementing quality assurance processes, and conducting audits to assess adherence to quality standards.

Key Responsibilities:
  • Ensure compliance with industry regulations and standards in line with client requirements.
  • Develop and implement quality assurance processes to maintain product quality and safety.
  • Conduct audits (stage 1 and 2) to assess adherence to quality standards and provide guidance on regulatory requirements.
  • Collaborate with teams to maintain product quality and safety and navigate regulatory submissions for products.
  • Stay updated on evolving regulatory requirements and assist in resolving compliance issues and implementing corrective actions.
Requirements:
  • A degree in medical engineering or a life sciences subject will be beneficial, alongside a lead auditor qualification.
  • Experience working in the medical device sector is essential, with a proven track record of managing clinical evaluations, technical file creation, and risk management.
  • Proven experience of working to ISO13485 and in a regulatory affairs and quality assurance capacity.
  • The successful candidate will ideally have 5+ years of experience in a similar role.

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



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