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Regulatory Affairs Specialist

2 months ago

Aylesbury, Buckinghamshire, United Kingdom Cure Talent Full time
About the Role

Cure Talent is seeking a highly skilled Regulatory Affairs Engineer to join a leading MedTech manufacturer in the home counties. As a key member of the Regulatory and Quality team, you will play a crucial role in ensuring the company's products and systems comply with applicable regulations and standards.

Key Responsibilities
  • Collaborate with internal departments, external regulators, suppliers, and customers to ensure ongoing product and systems compliance.
  • Assist in the maintenance and review of technical product files, including the transition to MDR.
  • Work with the design department to ensure regulatory compliance of current and new products.
  • Develop and maintain technical documentation, including risk assessments, test reports, and other relevant documents.
  • Coordinate with internal departments, Competent Authorities, and our Notified Body on product and company registrations.
  • Investigate and resolve NCRs, customer complaints, CAPA reports, and return in warranty failures, implementing corrective and preventative actions to improve processes.
Requirements
  • Proven experience in Regulatory Affairs within the Medical Device sector.
  • Strong understanding of quality and regulatory compliance of systems and products.
  • Broad background in electro/mechanical products and an understanding of regulatory requirements.
  • Experience with medical standards and European/FDA regulations, such as ISO 13485, EC 93/42, and MDR.
  • Knowledge of Cybersecurity, AI/ML, HFE, Usability, Software Development, and/or Biocompatibility is highly advantageous.