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Regulatory Compliance Expert

vor 2 Wochen


Basel, Basel-Stadt, Schweiz KVALITO AG Vollzeit

KVALITO AG Overview

We are a leading consulting firm in the life sciences and healthcare sectors, founded in 2013. Our mission is to empower high-performing individuals and create transformative solutions for our clients.

Our company values include embracing diversity, equity, and inclusion in every aspect of our work. We foster a results-oriented culture that balances excellence with empathy, utilizing technology and human-centric approaches to drive impactful results.

Job Description: Medical Device Specialist

The core mission of the Medical Device Specialist is to ensure compliance with EU Medical Device Regulation (MDR 2017/745) and facilitate the submission and approval processes for combination products involving medical device components.

Responsibilities

  • Oversee Notified Body Opinion submissions for products such as VAY736, TQJ230, Cosentyx, and Kesimpta, ensuring compliance with regulatory timelines and requirements.
  • Track submission progress, align with stakeholders, and escalate issues to senior leadership when necessary.