Regulatory Affairs Specialist
Vor 4 Tagen
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. With Indegene, you gain a unique career experience that celebrates entrepreneurship, innovation, collaboration, and empathy.
As a Regulatory Affairs Consultant, you will be responsible for providing expert Germany Medical Device Promotion-related regulatory advice to the Indegene team. You will ensure that client project requirements are met, and provide guidance on standards pertaining to advertising and promotion of medical devices in Germany, as well as EU and global regions.
Key Responsibilities:- 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
- 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 analyse complex regulatory issues, propose effective solutions, and make sound recommendations to stakeholders
We are an Equal Opportunity Employer and are 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. All employment decisions, from hiring to separation, will be based on business requirements, candidate's merit and qualification.
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