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Regulatory Affairs Specialist

2 months ago

Aylesbury, Buckinghamshire, United Kingdom Cure Talent Full time
Regulatory Affairs Engineer Opportunity

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.

As the new Regulatory Affairs Engineer, you will work closely with the Head of QARA and as part of an established team of Regulatory and Quality professionals. Your responsibilities will include maintaining and developing technical files under MDR, assisting in the transition to MDR, and collaborating with internal departments and external regulators to ensure ongoing product and systems compliance.

Key Responsibilities:

  • Work with internal departments and external regulators to ensure ongoing product and systems compliance.
  • Maintain and review technical product files and assist in the continued transfer to the MDR.
  • Collaborate with the design department to ensure ongoing regulatory compliance of current and new products.
  • Produce technical documentation, such as risk assessments and test reports.
  • Work with internal departments, Competent Authorities, and our Notified Body 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 of interpreting and implementing standards and regulations.
  • Broad background in quality and regulatory compliance of systems and products.
  • Broad background in electro/mechanical products, along with an understanding of the impact of regulatory requirements.
  • Experience of medical standards and European/FDA regulations, such as ISO 13485 and MDR.

If you have the necessary skills and experience, we encourage you to apply or contact Kris Holmes to discuss further.