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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 Specialist to join our team. As a Medical Device Regulatory Consultant, you will be responsible for providing expert regulatory advice to our clients and ensuring compliance with UK medical device regulations.

Key Responsibilities
  • Provide guidance on UK medical device promotion regulations and standards
  • Review and approve medical device promotional and non-promotional materials for compliance with UK regulations
  • Collaborate with internal teams to ensure regulatory requirements are met
  • Develop and maintain strong relationships with clients and stakeholders
  • Analyze complex regulatory issues and propose effective solutions
Requirements
  • Life science graduate or post-graduate degree
  • Regulatory Affairs/Compliance experience in medical device regulations and standards
  • Strong foundation in medical device regulatory affairs
  • Experience with UK, EU, and global medical device regulations
  • Excellent communication and analytical skills
About Indegene

Indegene is a technology-led healthcare solutions provider that partners with life science organizations to provide effective, AI-enabled material review and compliance solutions. We offer comprehensive medical, regulatory, and editorial review services, as well as operations support through a team of 350+ experienced professionals.