Regulatory Affairs Specialist

vor 1 Woche

Hamburg, Hamburg, Deutschland Indegene Vollzeit

About Indegene

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.

Our Mission

We believe in creating leaders of tomorrow and mentor our leads to help them grow and nurture them as people managers and account managers. We are a rapidly growing global organization scouting for the best talent for this phase of growth.

Job Summary

We are 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. The regulatory 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.

Key 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.

Requirements

  • 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

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. All employment decisions, from hiring to separation, will be based on business requirements, candidate's merit and qualification.

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