Regulatory Affairs Specialist

3 weeks ago


Bristol, Bristol, United Kingdom Computerworld Personnel Ltd Full time
Regulatory Affairs Consultant

We are seeking a highly skilled Regulatory Affairs Consultant to join our team at Computerworld Personnel Ltd. As a key member of our team, you will be responsible for ensuring compliance with industry regulations and standards in the medical device sector.

Key Responsibilities:
  • Develop and implement quality assurance processes to ensure adherence to regulatory requirements.
  • Conduct audits to assess compliance with 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 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.

Why this role? This role will provide you with the opportunity to work with a wide variety of medical device businesses, ranging from family businesses to multinationals. You will have the chance to develop and implement quality assurance processes, conduct audits, and provide guidance on regulatory requirements.

What we offer: A competitive salary and benefits package, including life insurance, sick pay package, and hybrid working model.



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