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Regulatory Affairs Specialist

4 months ago

Hertfordshire, United Kingdom Zest Scientific Full time

Zest Scientific is actively recruiting for a Senior Regulatory Specialist in the field of medical devices for a leading global drug development organization. We are seeking a motivated individual with substantial experience in Medical Device Regulation, particularly in the areas of combination products, drug/device, and in vitro diagnostics (IVDs). If you possess the required expertise and are looking to advance your career in a dynamic and challenging environment, we would like to hear from you.



Please note, this role cannot offer sponsorship or relocation support.




The candidate:



  • With a good understanding of the medical devices industry (coupled with some work in the pharmaceutical sector), you will leverage your regulatory knowledge and experience to deliver on required project work.
  • Experience of combination products, drug/device and IVDs.
  • With broad and comprehensive expertise within the Regulatory environment you will lead project work and partner with the business to solve complex regulatory issues that impact the department or wider business.
  • Contributes to development of strategic plans and goals.
  • Actively contributes to the learning & development of other departmental members.
  • An ability to understand scientific and technical information relating to an assigned portfolio of company products.
  • You will hold a scientific degree



The role:



  • Support the team in ensuring that regulatory requirements are met for Clinical Trial Applications that involve Medical Devices of any nature (e.g.: physical devices, digital devices, in-vitro diagnostics, etc)
  • Continuously monitor the changes to the UK Regulatory environment and provide an impact assessment on changes to the current framework and/or implementation of new Regulations
  • Be part of Trade Associations (e.g.:ABHI, ABPI, MedTech, etc) working groups and gather regulatory intelligence
  • Keep track of changes and/or implementation of regulations relevant to medical devices, such as (but not limited to) Sustainability/Environment, etc
  • Provide support for the implementation/adaptation of the medical device structure across the UK
  • Provide regulatory advice to project teams
  • Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance
  • Advise the manufacturers/global team to obtain and maintain a UKCA mark and/or any relevant regulatory milestone that concern the UK
  • Support the teams in any interaction with the MHRA that concerns medical devices
  • Provide training to people on medical device regulation and all its related aspects
  • Provide regulatory expertise on new product development
  • Support the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information
  • Assist in reviewing product and process documentation for assigned projects to ensure compliance with requirements, as well as monitor renewals to strict deadlines
  • Act as liaison between multiple project teams to obtain significant information as well as answer queries that may arise
  • Assess changes to existing products and company practices and provide an impact assessment, where necessary
  • Review Marketing materials and provide advice to the commercial teams on business-related activities