Regulatory Affairs Specialist

vor 1 Monat


Solothurn, Solothurn, Schweiz Ypsomed Vollzeit

About the Role

We are seeking a highly skilled Regulatory Affairs Manager to support our rapidly developing Diabetes Care (active and connected devices) team.

Main Responsibilities

  • Develop and implement regulatory strategies to ensure compliance with EU and US regulations.
  • Prepare and submit product submission documents to regulatory authorities.
  • Partner with business stakeholders to ensure regulatory requirements are met.
  • Communicate and correspond with regulatory authorities.
  • Cooperate in QMS ISO and CFR audits.
  • Perform general QM tasks, including creation of Q-documents and training.

About You

  • University degree in Engineering or Natural/Medical Sciences or equivalent experience.
  • At least 4 years of professional experience in Regulatory Affairs with a focus on medical devices.
  • Expertise in Active Medical Devices related regulations and guidance documents in EU and US.
  • Excellent organizational and people skills.
  • Very good English knowledge (Level C2 or MT).

About Ypsomed

Ypsomed is a successful, rapidly growing, family-owned company headquartered in Burgdorf (CH) with various production sites and subsidiaries around the world. We develop and produce injection and infusion systems for self-medication with the Ypsomed Group. Our market-leading products and solutions enable people all over the globe to self-treat chronic diseases such as diabetes, obesity, or certain types of cancer, and provide them with the greatest possible quality of life.



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