Regulatory Affairs Specialist

1 month 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.
  • Conduct audits (stage 1 and 2) to assess adherence to quality standards.
  • Provide guidance on regulatory requirements.
  • Collaborate with teams to maintain product quality and safety.
  • Navigate regulatory submissions for products.
  • Stay updated on evolving regulatory requirements.
  • 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.
  • Proven experience in managing clinical evaluations, technical file creation, and risk management.
  • Working in a regulatory affairs and quality assurance capacity will be required for this position.

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. For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.



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