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Regulatory Affairs Specialist
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We are a technology-led healthcare solutions provider driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that's bold, industrious, and nimble.
Indegene is seeking a Germany-based Consultant with Regulatory or Compliance or Nominated Signatory Review experience for Medical Devices promotional and scientific communication materials on a 3-4 months contract starting October 2024.
Job Summary:The Regulatory Affairs Consultant will work with Indegene's material review team to support its engagement with the medical device client partner and serve as a consultant to assist as an MLR SME (especially on medical device promotion regulations) on a medical device project.
Responsibilities:- Provide expert Germany 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 Germany (and if possible, in EU and global regions).
- Provide guidance on Germany Regulatory Requirements for promotional material review for medical devices.
- Provide guidance on review workflow for medical device promotional materials for Germany 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 Germany market.
- 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 Germany, EU and global medical device regulations.
Indegene is an equal opportunities employer and welcomes applications from all qualified candidates. Please upload your CV in English.
