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Regulatory Strategy Lead

vor 2 Monaten


Burgdorf BE, Bern, Schweiz Ypsomed Vollzeit

About the Role

We are seeking a highly skilled Regulatory Affairs professional to join our team at Ypsomed. As a Regulatory Affairs Specialist, you will play a critical role in ensuring the compliance of our combination products and medical devices with regulatory requirements.

Key Responsibilities

  • Develop and implement regulatory strategies to support the development, support, and deployment of combination products and medical devices.
  • Manage regulatory responsibilities associated with product submissions, including preparation of worldwide product submission documents.
  • Partner with business stakeholders to ensure regulatory compliance and support life-cycle management activities.
  • Review quality agreements with customers on regulatory aspects and cooperate in QMS ISO and CFR audits.
  • Lead or support continuous improvement initiatives to enhance regulatory processes and procedures.

Requirements

  • University degree in Engineering or Natural/Medical Sciences or equivalent experience.
  • At least 2 years of professional experience in Regulatory Affairs with focus on combination products and/or medical devices.
  • Project Management competences preferred.
  • Excellent organizational and people skills.
  • Ability to work in an international cross-functional organization.
  • Very good English knowledge (C2), German is a plus (B1).

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-treatment despite chronic diseases such as diabetes, obesity, or certain types of cancer.