Regulatory Affairs Specialist

1 month ago

London, Greater London, United Kingdom Cure Talent Ltd Full time
Regulatory Affairs Engineer Opportunity

Cure Talent Ltd is excited to be working with a leading MedTech manufacturer, specialising in innovative surgical products, based in the heart of the home counties. Due to their exceptional continued growth, we have a superb opportunity for a Regulatory Affairs Engineer to join the team.

As the new Regulatory Affairs Engineer, you will be working closely with the Head of QARA and as a part of an established team of Regulatory and Quality professionals. You will be involved in Product Registrations, Post Market Surveillance, Customer Complaints and CAPA reporting.

Key Responsibilities
  • Work with the design department to ensure ongoing regulatory compliance of current and new products.
  • Collaborate with a team of design engineers to produce a variety of technical documentation (such as risk assessments, test reports, etc).
  • Assist in the actioning, monitoring and reviewing of NCRs, customer complaints, CAPA reports and return in warranty failures, assisting with the identification and implementation of corrective / preventative actions to continuously improve on these.
Requirements
  • Proven Regulatory Affairs Experience within the Medical Device sector.
  • Broad background in quality and regulatory compliance of systems and products essential.
  • Broad background in electro/mechanical products essential, along with an understanding of the impact of regulatory requirements.
  • Experience of medical standards and European/ FDA regulations such as ISO 13485, EC 93/42 and MDR highly desirable.
  • Experience of Cybersecurity, AI/ML, HFE, Usability, Software Development and/or Biocompatibility is highly advantageous.

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