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Regulatory Affairs Specialist

2 months ago

London Area, United Kingdom Indegene Full time
About the Role

Indegene is seeking a highly skilled Regulatory Affairs Consultant to join our team. As a Regulatory Affairs Consultant, you will be responsible for providing expert guidance on UK Medical Device Promotion related Regulatory requirements to our team.

Key Responsibilities
  • Provide guidance on standards pertaining to advertising and promotion of medical devices in the UK (and if possible, in EU and global regions).
  • Provide guidance on UK Regulatory Requirements for promotional material review for medical devices.
  • Provide guidance on review workflow for medical device promotional materials for the UK market.
  • Provide strategic input and guidance on regulatory affairs matters, including understanding the collaboration between global and local markets for medical device promotional materials and associated review workflow for repurposing content, understanding regulatory submission guidelines, filing, negotiations, and amendments, which includes obtaining, assessing and summarizing scientific and other technical information specific for the UK market.
Requirements
  • Life science graduate/post-graduate.
  • Regulatory Affairs/Compliance professional with experience in Medical Device regulations and standards for device promotion and scientific communication, with 2 years' experience in review and approval of medical device promotional and non-promotional materials.
  • Strong foundation in medical device regulatory affairs, with a total of 2-3 years working with a range of medical devices (Class 2 and above is preferred).
  • Has experience with and understands UK, EU and global medical device regulations.
  • Ability to build and maintain strong and collaborative working relationships with internal and external contacts.
  • Ability to analyze complex regulatory issues, propose effective solutions, and make sound recommendations to stakeholders.