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Regulatory Affairs Specialist
vor 2 Monaten
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.
