Regulatory Affairs Specialist
Vor 6 Tagen
We are a technology-driven healthcare solutions provider, dedicated to empowering healthcare organizations to be future-ready. Our purpose is to enable accelerated, global growth opportunities for talented individuals who are bold, industrious, and nimble. At Indegene, you'll experience a unique career journey that celebrates entrepreneurship, passion, innovation, collaboration, and empathy.
Job SummaryWe're seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Medical Device Compliance Expert, you will provide expert regulatory advice to our team, ensuring client project requirements are met. Your responsibilities will include:
Key Responsibilities:- Providing guidance on standards pertaining to advertising and promotion of medical devices in Germany (and if possible, in EU and global regions).
- Providing guidance on Germany Regulatory Requirements for promotional material review for medical devices.
- Providing guidance on review workflow for medical device promotional materials for Germany market.
- Providing 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.
- 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.
We're looking for a talented individual who is passionate about regulatory affairs and has a strong foundation in medical device regulations. If you're a team player with excellent communication skills and a keen eye for detail, we'd love to hear from you.
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