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Regulatory Affairs Specialist

2 months ago

London, Greater London, United Kingdom Indegene Full time
Job Title: Regulatory Affairs Consultant

We are seeking a highly skilled Regulatory Affairs Consultant to join our team at Indegene. As a key member of our regulatory team, you will be responsible for providing expert guidance on UK medical device promotion regulations and standards.

About the Role:

As a Regulatory Affairs Consultant, you will work closely with our material review team to support our engagement with medical device clients. Your expertise will be invaluable in ensuring compliance with UK, EU, and global medical device regulations.

Responsibilities:
  • Provide guidance on UK medical device promotion regulations and standards
  • Review and approve medical device promotional and non-promotional materials
  • Collaborate with internal and external stakeholders to ensure regulatory compliance
  • Analyse 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
  • Ability to build and maintain strong working relationships
  • Ability to analyse complex regulatory issues and propose effective solutions
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.

We are an Equal Opportunity Employer and are committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics.