Regulatory System Manager
AU25 Pall Australia Pty Ltd
Apply to this jobBring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career.
Learn about the Danaher Business System which makes everything possible.
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.
Summary
Manage regulatory documentation, ensure compliance, support product development, and liaise with authorities.
Job title
Regulatory System Manager
Experience level
few years
Minimum experience
0+ years exp
Industry
life sciences
Location requirements
Uppsala, Sweden, on-site, no remote work allowed
Salary
Not specified
Management role
No
Required skills
Preferred skills
Specializations
Structured locations inferred from the posting.
Uppsala, Sweden