Regulatory System Manager

As a Regulatory System Manager you'll get the chance to interpret different regulations as they apply to Cytivas products, processes and procedures. You will also advise on impact of regulations, devises strategies for compliance, and liaison with regulatory bodies. The position will also work with investigations and resolve compliance problems, questions and complaints. Audits and evaluates current policies, procedures, and documentation will also be a part of the responsibilities.

This position reports to the Sr. Regulatory Manager for chemical and consumable products and is a part of the Product Regulatory Compliance department located in Uppsala.

What You'll Do

• Maintain and manage regulatory documentation used in NPDs (New Product Development) to secure compliance to relevant regulations for market access, e.g. safety data sheets
• Coordinate and collaborate with IT to ensure regulatory systems are up to date and integrated with other Cytiva systems, including acquired businesses
• Support other users of regulatory systems in how to best create compliant documentation
• Monitor and review change requests/orders and regulatory changes to ensure that compliance requirements are met and maintained.
• Drive simple, cost-efficient and pragmatic solutions to issues related to regulatory requirements in NPDs and other projects.
  
  

Who you are

• Bachelors' Degree in Chemistry, Biochemistry or related field with a few 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
• Knowledge around environmental and chemistry regulations, e.g. familiar with REACH, GHS labeling, hazardous chemicals, and similar regulations
• Familiarity and interest in maintaining IT systems

It would be a plus if you also possess previous experience in:

• Communicating with authorities, e.g. chemistry and border control authorities
• Written and spoken Swedish

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.