Regulatory Affairs Specialist

5 days ago

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

About Us

Indegene is a technology-led healthcare solutions provider, driven by a purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that's bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, innovation, collaboration, and empathy.

Our Mission

We understand that you're looking for growth in your career and we'd love for you to join us on our journey. At Indegene, our roles come with the excitement you require at this stage of your career, with the reliability you seek. We believe in creating leaders of tomorrow and mentor our leads to help them grow and nurture them as people managers and account managers.

Job Summary

We're scouting for the best talent for this phase of growth. With us, you're at the intersection of two of the most exciting industries - healthcare and technology. We offer global opportunities with fast-track careers while you work with a team that's fueled by purpose. The combination of this will lead to a truly differentiated experience for you.

Key Responsibilities

  • Provide expert UK Medical Device Promotion related Regulatory advice to the Indegene team with direct or indirect involvement in the client project, ensuring the client project requirements are met.
  • 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.

Equal Opportunity Employer

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate's merit, and qualification.

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