Danaher Corporation Regulatory Compliance Leader in Eysins, Switzerland
Help us improve access to life-changing therapies that can transform human health
We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020.
Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services - the pots, pans, soups and sauces - they need to work better, faster and safer, leading to better patient outcomes.
We are looking for a Regulatory Compliance Leader to work with our expert regulatory team with employees across the world. Do you have a passion for product compliance? Then we would love to hear from you.
What you’ll do
This role is responsible for evaluating products to ensure they will meet applicable regulations and standards and will be a key contributor to R&D during the development process for design and compliance. The Regulatory Compliance Leader will interpret the impact of new or changing requirements and recommend compliance strategies to the product teams. This role is mainly responsible for evaluating non-medical laboratory products.
• Support the development of new products within the Cytiva business
• Core team member for New Product Introduction (NPI) projects to secure compliance to relevant regulations to get market access.
• Review change requests/orders to ensure that Compliance requirements are met and maintained.
• Maintain awareness of applicable regulations and monitor activities related to changes to regulations.
• Participate/support Project Management Office (PMO) projects.
• Supporting the Operations Leaders within the Product and Technology Compliance team to form and drive strategies.
• Drive compliant, simple, cost-efficient and pragmatic solutions to issues related to regulatory requirements in NPI’s and other projects.
Who you are
• Bachelors' Degree in electrical and/or mechanical engineering or related discipline
• 5+ years relevant working experience
• Experience with Product regulations, QA/RA, other regulatory areas or experience with Cytiva’s product portfolio and an interest to learn about regulatory compliance.
• Knowledge around the Cytiva portfolio and the Cell & Gene Therapy business
• Knowledge around environmental, chemistry and hardware regulations, e.g.
• EMI/EMC, machinery directive, low voltage directive, product safety standards
• CE marking, NRTL marking (UL, TUV, ETL)
• Experience with authorities and testing institutes, e.g. Intertek, TUV.
Who we are
Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you’ll feel right at home here. If you’re flexible, curious and relentless, you’ll belong. If you are excited about a global culture, this can be the place to further your career.
Want to know more? Experience life at Cytiva on our Careers website, Instagram channel and LinkedIn page!
Cytiva is global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to advance and accelerate therapeutics. As a trusted partner to customers that range in scale and scope, Cytiva brings efficiencies to research and manufacturing workflows, ensuring the development, manufacture and delivery of transformative medicines to patients.
Cytiva is part of the Danaher family of companies, a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.