Regulatory Affairs Specialist

7 days ago

Neath, Neath Port Talbot, United Kingdom Hunter Selection Full time
About the Role

We are seeking a highly experienced Regulatory Affairs Specialist to join our client, a leading medical device company. As a key member of the team, you will be responsible for ensuring compliance with industry regulations and standards.

Key Responsibilities
  • Develop and implement quality assurance processes to ensure compliance with regulatory requirements.
  • Conduct audits to assess adherence to quality standards and identify areas for improvement.
  • Provide guidance on regulatory requirements and collaborate with teams to maintain product quality and safety.
  • Navigate regulatory submissions for products and stay up-to-date on evolving regulatory requirements.
  • Assist in resolving compliance issues and implementing corrective actions.
Requirements
  • A degree in medical engineering or a life sciences subject is 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 is required.
  • Working in a regulatory affairs and quality assurance capacity is essential for this position.
  • The successful candidate will ideally have 5+ years of experience.
About Our Client

Our client is a leading medical device company that is committed to delivering high-quality products and services. They are seeking a highly experienced Regulatory Affairs Specialist to join their team and contribute to their success.

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