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Regulatory Affairs Specialist

2 months ago

London, Greater London, United Kingdom Indegene Full time
Job Description

Indegene is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Medical Device Compliance Expert, you will be responsible for providing expert advice on UK Medical Device Promotion regulations to our team.

Key Responsibilities:
  • Provide guidance on standards pertaining to advertising and promotion of medical devices in the UK 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.
  • Obtain, assess, and summarize scientific and other technical information specific for the UK market.
Requirements:
  • Life science graduate/post-graduate with a strong foundation in medical device regulatory affairs.
  • Regulatory Affairs/Compliance professional with experience in Medical Device regulations and standards for device promotion and scientific communication.
  • 2-3 years of experience in review and approval of medical device promotional and non-promotional materials.
  • Strong understanding of UK, EU, and global medical device regulations.
  • Ability to analyze complex regulatory issues, propose effective solutions, and make sound recommendations to stakeholders.
What We Offer:
  • A dynamic and entrepreneurial organization with a strong commitment to innovation and excellence.
  • A global opportunity with fast-track careers and a chance to work with a team that is fueled by purpose.
  • A collaborative and inclusive work environment that values diversity and promotes equal opportunities.