Device Project Leader

Vor 4 Tagen


Basel, Schweiz Sobi group Vollzeit

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application

At Sobi, the work we do every day redefines the standards of care and transforms the lives of people living with rare diseases.

As a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly and always challenging the status quo.

We are committed to an inclusive, sustainable and flexible workplace that fosters growth and development.

Job Description

At Sobi, we are working on a broad range of products with very different indications and ways of administration. This keeps working interesting as you deal with diverse challenges but also requires you to be ready for such an environment.

As a Medical Device and Combinations Products expert, you own your assigned projects, are responsible for the project's progress, and ensure that everything required to make it happen is available and/or performed. You communicate with other functions, explain the needs for the combination product development, and also listen to their needs.

Key Responsibilities

  • In-depth knowledge of the regulatory requirements for medical devices and combination products.
  • Knowledge and experience in writing DHF/Technical File documents for submissions in EU, US, and the rest of the world.
  • Prepare documentation and answer questions from Notified Bodies as well as Health Authorities and explain Sobi's position during audits.
  • Evaluate existing Technical Documentation for marketed products and drive remediation projects when necessary.
  • Communicate with stakeholders from different functions within the organization.
  • Ensure efficient information flow and project progress.
Qualifications

You have a “Make-it-happen

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