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Regulatory Engineer

2 months ago

London, Greater London, United Kingdom Austin Vita Full time

Austin Vita is seeking a highly skilled Regulatory Engineer to join our client, a leading medical device company that designs, develops, and manufactures innovative products for global markets.

Key Responsibilities:

  • Collaborate with internal departments and external stakeholders to ensure ongoing product and systems compliance with applicable regulations and standards.
  • Work closely with the design department to ensure regulatory compliance of current and new products.
  • Contribute to the development of technical documentation, including essential requirements, risk assessments, and test reports.
  • Produce documentation in compliance with relevant regulatory standards.
  • Assist in the actioning of regulatory requirements associated with non-conformities, customer complaints, and corrective actions.
  • Bring a broad background in regulatory compliance of systems and products within a quality management system.
  • A background in electro/mechanical products is highly desirable, along with an understanding of the impact of regulatory requirements.
  • Experience of medical standards and European/FDA regulations is highly desirable.
  • Experience of medical device manufacturing and medical standards is highly desirable.

Requirements:

  • Preferably degree educated in a technical subject, such as Engineering, or in another subject with experience in the technical industry.