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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.
- Guide on standards pertaining to advertising and promotion of medical devices in Germany, as well as in EU and global regions.
- Provide guidance on Germany Regulatory Requirements for promotional material review for medical devices.
- Offer 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.
Requirements:
- Life science graduate or post-graduate.
- Regulatory Affairs/Compliance professional with experience in Medical Device regulations and standards for device promotion and scientific communication.
- 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).
- Experience with and understanding of Germany, EU, and global medical device regulations.
What We Offer:
- Global opportunities with fast-track careers.
- A team fueled by purpose.
- A comprehensive medical, regulatory, and editorial review services as well as operations support through a team of 350+ experienced professionals.
Indegene is an Equal Opportunity Employer.
