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Regulatory Affairs Specialist
Il y a 2 mois
Indegene is seeking a highly skilled Regulatory Affairs Consultant to join our team. As a key member of our regulatory team, you will be responsible for providing expert regulatory advice on medical device promotion in France and other regions.
Key Responsibilities:- Provide guidance on standards pertaining to advertising and promotion of medical devices in France and the EU.
- Review and approve medical device promotional and non-promotional materials for compliance with French regulatory requirements.
- Collaborate with our material review team to ensure client project requirements are met.
- Provide strategic input on regulatory affairs matters, including understanding the collaboration between global and local markets for medical device promotional materials.
- Life science graduate or post-graduate degree.
- 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 preferred).
- Experience with and understanding of Germany, EU, and global medical device regulations.
Please upload your CV in English. We look forward to hearing from you.
