Bring 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 Quality and Regulatory Support Specialist for Cytiva within our Customer Regulatory Support Team, you will be located in Kraków (this will be an on-site position). You will contribute to our success by providing support to our customers. You will ensure that all the required quality/regulatory support documents and subscriptions of regulatory documents are in place and provided to our customers. As a member of our Team, you will add value to BioProcess products and demonstrate commitment to customer satisfaction.
At Cytiva, our vision is to advance future therapeutics from discovery to delivery.
What you will do:
Support the Business and Customers in a global environment by providing quality documents and regulatory support in response to customers' requests for quality, regulatory and technical-related information as it pertains to Cytiva products.
Respond efficiently and promptly to customers’ regulatory based issues, which will include preparations and delivery of certificates, use of available internal and external databases and other relevant databases.
File and maintain complete documentation of questions and answers in databases; specify, prepare and update regulatory support documentation, including RSF (Regulatory Support Files), VG (Validation Guides), VSF (Validation Support Files), CCN (Change Control Notifications), statements, certificates and other regulatory related documentation for existing products.
Daily management of CRS (Customer Regulatory Support) queue in SFDC (Salesforce) case management.
Who you are:
Bachelor of Science in Chemistry, Biotechnology, Pharmacy or equivalent educational background.
Strong written and verbal communication skills, fluent in English.
Quality minded, collaborative, and customer oriented with excellent written and verbal communication skills.
It would be a plus if you also possess previous experience in:
Knowledge of regulatory requirements in Pharma/MD/Life Science industry.
High ability to work independently and cross-functionally within global teams.
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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.
