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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 affairs team, you will be responsible for providing expert guidance on regulatory requirements for promotional and scientific communication materials for medical devices in France and other global regions.
Key Responsibilities:
- Provide guidance on standards pertaining to advertising and promotion of medical devices in France and other EU and global regions.
- Review and approve medical device promotional and non-promotional materials for compliance with France regulatory requirements.
- Develop and implement regulatory strategies to ensure compliance with France and EU regulations.
- Collaborate with internal stakeholders to ensure alignment with regulatory requirements and industry standards.
Requirements:
- 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 is preferred).
- Experience with and understanding of Germany, EU and global medical device regulations.
- Ability to build and maintain strong and collaborative working relationships with internal and external contacts.
- Ability to analyze complex regulatory issues, propose effective solutions, and make sound recommendations to stakeholders.
About Indegene:
Indegene is a technology-led healthcare solutions provider that partners with life science organizations to provide effective, AI-enabled material review and compliance solutions. We offer comprehensive medical, regulatory, and editorial review services as well as operations support through a team of 350+ experienced professionals.
Equal Opportunity Employer:
Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics.
