Regulatory Affairs Specialist

3 hours ago

Port Talbot, United Kingdom Hunter Selection Full time
Job Title: 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.

About the Role:

We are seeking an experienced Regulatory Affairs Consultant to join our team. As a key member of our regulatory affairs department, 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.
  • Proven experience of working to ISO13485.
  • Working in a regulatory affairs and quality assurance capacity will be required for this position.
  • The successful candidate will ideally have 5+ years of experience.
What We Offer:
  • A competitive salary and benefits package.
  • The opportunity to work with a leading medical device business.
  • A dynamic and supportive team environment.

If you are a motivated and experienced Regulatory Affairs Consultant looking for a new challenge, please apply with your CV and cover letter.

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