Regulatory Affairs Manager.

vor 3 Wochen

Bern, Schweiz TN Switzerland Vollzeit

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  • Manage regulatory responsibilities associated with the development, support, and deployment of combination products and medical devices within the business area delivery systems
  • Manage the development and implementation of regulatory strategies
  • Support and prepare worldwide product submission documents
  • Partner with business stakeholders on different levels
  • Review quality agreements with customers on regulatory aspects
  • Cooperation in QMS ISO and CFR audits
  • Lead or support continuous improvement initiatives

Your profile

  • University degree preferably 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
  • Excellent organizational and people skills
  • Ability to work in an international cross-functional organization
  • Very good English knowledge (C2), German is a plus (B1)

Your main tasks

  • Manage regulatory responsibilities associated with the development, support, and deployment of combination products and medical devices within the business area delivery systems
  • Manage the development and implementation of regulatory strategies
  • Support and prepare worldwide product submission documents
  • Partner with business stakeholders on different levels
  • Support life-cycle management activities
  • Review quality agreements with customers on regulatory aspects
  • Cooperation in QMS ISO and CFR audits
  • Lead or support continuous improvement initiatives

Your benefits

  • Shiftwork, annual working hours, part-time
  • Work where and when you want (in Switzerland)
  • Up-to-date production, offices, break areas
  • Ypsomed covers % of the pension contributions
  • Charging stations, Swiss Half Fare Card, parking, close to public transport
  • Affordable or free gyms all over Switzerland
  • Financial contributions to childcare

About Ypsomed

Ypsomed - making the treatment of chronic diseases possible. More than 2, employees worldwide develop and produce injection and infusion systems for self-medication with the Ypsomed Group. We are a successful, rapidly growing, family-owned company headquartered in Burgdorf (CH) with various production sites and subsidiaries around the world. With our market-leading products and solutions, we enable people all over the globe to self-treatment. Despite chronic diseases such as diabetes, obesity, or certain types of cancer, they are provided with the greatest possible quality of life.

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