Regulatory Affairs Specialist

Vor 4 Tagen


Deutschland Indegene Vollzeit
Join Indegene's Team as a Regulatory Affairs Consultant

We are a technology-led healthcare solutions provider driven by our purpose to enable healthcare organizations to be future-ready. Our accelerated, global growth opportunities are ideal for talent that's bold, industrious, and nimble.

As a rapidly growing global organization, we're scouting for the best talent to support our next phase of growth. We offer global opportunities with fast-track careers while working with a team fueled by purpose.

Key Responsibilities:

  • Support Indegene's material review team in engaging with medical device client partners.
  • Assist as an MLR SME (Medical Literature Review Specialist) on medical device projects, focusing on medical device promotion regulations.
  • Provide expert Germany Medical Device Promotion related Regulatory advice to the Indegene team.
  • Ensure client project requirements are met, with direct or indirect involvement in the client project.

Requirements:

  • Life science graduate or 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 Germany, EU, and global medical device regulations.

What We Offer:

  • Global opportunities with fast-track careers.
  • A team fueled by purpose.
  • A rapidly growing global organization.

Indegene is an Equal Opportunity Employer.



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