Regulatory Affairs Specialist

2 months ago

London, Greater London, United Kingdom Cure Talent Ltd Full time

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

About the Role

As the new Regulatory Affairs Specialist, you will be working closely with the Head of Quality Assurance 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.

About Cure Talent Ltd

Cure Talent Ltd is a leading recruitment agency specialising in the placement of professionals in the MedTech industry. We work closely with our clients to understand their needs and provide tailored solutions to meet their requirements.

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