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Regulatory Affairs Specialist

2 months ago

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

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

Key Responsibilities:

  • Work closely with the Head of Quality Assurance and Regulatory Affairs to ensure ongoing product and systems compliance to applicable regulations and standards.
  • Maintain and develop technical files under MDR, assisting in the transition to MDR.
  • Assist in product registrations, post-market surveillance, customer complaints, and CAPA reporting.
  • Collaborate with design engineers to produce technical documentation, such as risk assessments and test reports.
  • Work with internal departments, Competent Authorities, and Notified Bodies on product and company registrations.
  • Assist in the actioning, monitoring, and reviewing of NCRs, customer complaints, CAPA reports, and return in warranty failures.

Requirements:

  • Proven Regulatory Affairs experience within the Medical Device sector.
  • Experience in interpreting and implementing standards and regulations.
  • Broad background in quality and regulatory compliance of systems and products.
  • Broad background in electro/mechanical products, with an understanding of the impact of regulatory requirements.
  • Experience with medical standards and European/FDA regulations, such as ISO 13485, EC 93/42, and MDR.
  • Experience with Cybersecurity, AI/ML, HFE, Usability, Software Development, and/or Biocompatibility is highly advantageous.

About Cure Talent

Cure Talent is a leading recruitment agency specializing in the MedTech industry. We are passionate about connecting talented professionals with exciting career opportunities.