Regulatory Affairs Manager

vor 3 Wochen

Burgdorf BE, Bern, Schweiz Ypsomed Vollzeit
  • 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 device
  • Excellent organizational and people skills
  • Ability to work in an international cross-functional organization
  • Very good English knowledge (C2), German is a plus (B1)

Working hours

Shiftwork, annual working hours, part-time

FlexWork

Work where and when you want (in Switzerland)

Up-to-date work environment

Up-to-date production, offices, break areas

Pension fund

Ypsomed covers % of the pension contributions

Mobility support

Charging stations, Swiss Half Fare Card, parking, close to public transport

Free sport facilities

Affordable or free gyms all over Switzerland

Family friendly

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.

#J-18808-Ljbffr

  • Regulatory Affairs Professional

    vor 2 Wochen

    Burgdorf BE, Bern, Schweiz Ypsomed Vollzeit

    Job Overview">The Regulatory Affairs Manager role involves overseeing regulatory responsibilities related to the development, support, and deployment of combination products and medical devices within our business area delivery systems.">Your Profile">This position requires a university degree in Engineering or Natural/Medical Sciences, or equivalent...

  • Regulatory Affairs Manager

    vor 1 Woche

    Burgdorf BE, Bern, Schweiz Ypsomed Vollzeit

    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...

  • Regulatory Strategy Developer

    vor 2 Wochen

    Burgdorf BE, Bern, Schweiz Ypsomed Vollzeit

    About the Role">This Regulatory Affairs Manager will oversee regulatory responsibilities associated with the development, support, and deployment of combination products and medical devices.The successful candidate will develop and implement regulatory strategies to ensure compliance with relevant regulations.">Key Responsibilities">Manage the development...

  • Compliance Manager for Combination Products

    vor 2 Wochen

    Burgdorf BE, Bern, Schweiz Ypsomed Vollzeit

    About the Job">The Regulatory Affairs Manager will be responsible for ensuring compliance with relevant regulations and developing and implementing regulatory strategies.The successful candidate will work closely with business stakeholders and review quality agreements with customers on regulatory aspects.">Key Skills">University degree in Engineering or...

  • Medical Device Compliance Expert

    Vor 5 Tagen

    Burgdorf BE, Bern, Schweiz Ypsomed Vollzeit

    About the Role">This Regulatory Affairs Manager will be responsible for managing regulatory responsibilities associated with combination products and medical devices.The successful candidate will develop and implement regulatory strategies to ensure compliance with relevant regulations.">Key Requirements">A university degree in Engineering or Natural/Medical...

  • Manager Maintenance

    vor 2 Wochen

    Lengnau BE, Bern, Schweiz Gi Group Vollzeit

    For our client, an international pharmaceutical company, we are currently looking for a Manager Maintenance and Utilities.The Manager, Maintenance and Utilities is responsible for ensuring the efficient and compliant operation of all mechanical systems and non-electrical energy systems, such as boilers and clean steam, within the Lengnau facility.Position...

  • Thermo Fisher Scientific Senior Manager

    vor 2 Wochen

    Lengnau BE, Bern, Schweiz Thermo Fisher Scientific Inc. Vollzeit

    Job Summary">As a Sr Manager, Manufacturing Engineering, you will be responsible for leading the development and implementation of innovative solutions to drive productivity, efficiency, and quality in our manufacturing processes. This role requires strong technical expertise, leadership skills, and the ability to collaborate effectively with...

  • Manufacturing Engineering Manager

    vor 2 Wochen

    Lengnau BE, Bern, Schweiz Thermo Fisher Scientific Inc. Vollzeit

    Company Overview">At Thermo Fisher Scientific, we are committed to making the world a healthier, cleaner, and safer place. Our Drug Substance Division is a world-class contract development and manufacturing organization (CDMO) that is revolutionizing the industry.">About the Role">We are seeking an experienced Sr Manager, Manufacturing Engineering to join...

  • Leiter Qualitätssicherung

    vor 1 Woche

    Burgdorf BE, Bern, Schweiz Alloga AG Vollzeit

    «Wir bauen auf die unterschiedlichen Erfahrungen, Fähigkeiten und Sichtweisen unserer Mitarbeitenden.» Leiter Qualitätssicherung (QS) (w/m) 80-100% 3400 Burgdorf Alloga AG Espace Mittelland (BE, FR, NE, JU, SO) Qualitätsmanagement / Regulatory Affairs Das kannst du bewirkenFührung, Entwicklung und gezielte Förderung des QS-Teams, um es...

  • Leiter Qualitätsmanagement

    vor 1 Woche

    Burgdorf BE, Bern, Schweiz Alloga AG Vollzeit

    «Werde auch du ein Teil unseres Teams und bring es voran.» Leiter Qualitätsmanagement (QM) und Fachverantwortliche Person (FvP) (w/m) 80-100% 3400 Burgdorf Alloga AG Espace Mittelland (BE, FR, NE, JU, SO) Qualitätsmanagement / Regulatory Affairs Das kannst du bewirkenSicherstellung der konsequenten Umsetzung von GDP-/GMP-Regularien sowie relevanten...

  • Project Management Innovation Engineer

    vor 1 Woche

    Burgdorf BE, Bern, Schweiz Ypsomed Vollzeit

    Perspektive. Ypsomade. Zur Verstärkung unseres motivierten Teams in der Innovation am Standort Burgdorf suchen wir eine dynamische und erfahrene Person für die Position des/der Project Managers/Managerin Innovation. Ihre Hauptaufgabe ist die erfolgreiche Gesamtleitung von Innovationsprojekten, von der Ideenfindung bis zum Proof of Concept von mechanischen...

  • Leiter Qualitätsmanagement

    vor 2 Wochen

    Burgdorf BE, Bern, Schweiz Alloga AG Vollzeit

    «Werde auch du ein Teil unseres Teams und bring es voran.» Leiter Qualitätsmanagement (QM) und Fachverantwortliche Person (FvP) (w/m) 80-100% 3400 Burgdorf Alloga AG Espace Mittelland (BE, FR, NE, JU, SO) Qualitätsmanagement / Regulatory Affairs Das kannst du bewirkenSicherstellung der konsequenten Umsetzung von GDP-/GMP-Regularien sowie relevanten...

  • Leiter Qualitätssicherung

    vor 2 Wochen

    Burgdorf BE, Bern, Schweiz Alloga AG Vollzeit

    «Wir bauen auf die unterschiedlichen Erfahrungen, Fähigkeiten und Sichtweisen unserer Mitarbeitenden.»Leiter Qualitätssicherung (QS) (w/m) 80-100% 3400 Burgdorf Alloga AG Espace Mittelland (BE, FR, NE, JU, SO) Qualitätsmanagement / Regulatory Affairs Das kannst du bewirkenFührung, Entwicklung und gezielte Förderung des QS-Teams, um es nachhaltig zu...

  • Quality Engineer

    vor 2 Wochen

    Burgdorf BE, Bern, Schweiz Ypsomed Vollzeit

    Entwicklung. Ypsomade. Im Bereich Quality Management, Regulatory & Medical Affairs in der Abteilung Quality Assurance suchen wir am Standort Burgdorf im Production Management Team eine kundenorientierte und qualitätsbewusste Persönlichkeit als Quality Engineer | - % Ref-Nr. 2 Arbeitsort: Burgdorf | Hybrid Helfen Sie uns, modernste...

  • Sr Manager, Manufacturing Engineering

    vor 2 Wochen

    Lengnau BE, Bern, Schweiz Thermo Fisher Scientific Vollzeit

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc. allowed; Loud Noises (Equipment/Machinery); No contact lens allowed; prescriptive glasses will be provided; Office; Some degree of...

  • Sr Manager, Manufacturing Engineering

    vor 2 Wochen

    Lengnau BE, Bern, Schweiz Thermo Fisher Scientific Inc. Vollzeit

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc. allowed; Loud Noises (Equipment/Machinery); No contact lens allowed; prescriptive glasses will be provided; Office; Some degree of...

  • Global Financial Operations Manager

    vor 3 Stunden

    Kirchberg BE, Bern, Schweiz ProAmpac Vollzeit

    Job Description:This role is key to achieving the organization's financial and operational goals by serving as a strategic business partner to plant and financial leaders.Responsibilities:Oversee and coordinate the preparation of monthly management accounts, ensuring compliance with tight corporate deadlines.Lead budget and forecast preparation, analyzing...

  • Quality Engineering Manager

    vor 1 Woche

    Lengnau BE, Bern, Schweiz Thermo Fisher Scientific Vollzeit

    RequirementsBachelor's degree in engineering, science, operations, or business (Master's degree preferred).10+ years of experience in GMP production and leading technical teams.Knowledge and experience in leading process automation teams in a GMP environment.Strong understanding of regulatory requirements and industry guidance.

  • Manager, QA Systems

    vor 1 Woche

    Lengnau BE, Bern, Schweiz Thermo Fisher Scientific Vollzeit

    : Lead and manage a team of 5-6 QA professionals, providing direction and support for their professional development. Provide oversight and supervision of the compliance activities within Lengnau site. Interact with varying levels of staff within the organization as well as with customers and auditors to determine and successfully implement compliance...

  • Process Automation Expert

    vor 2 Wochen

    Lengnau BE, Bern, Schweiz Thermo Fisher Scientific Inc. Vollzeit

    About the Team">Our Manufacturing Engineering and Process Automation teams are responsible for developing and implementing innovative solutions to drive productivity, efficiency, and quality in our manufacturing processes. As a Sr Manager, Manufacturing Engineering, you will be part of a collaborative and dynamic team that values expertise, creativity, and...