Overview
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. 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 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.
Responsibilities
* Provide regulatory support to Product Managers, Regions and customers by delivering quality documents and regulatory support in response to requests for quality, regulatory and technical information.
* Build and maintain knowledge of customers’ regulatory requirements related to the bioprocess business.
* Develop and update regulatory support documentation for products in customers’ regulated environments.
* Perform investigations and prepare and deliver statements and certificates.
* Participate in creating and updating guidelines and steering documents.
* Act as regulatory support expert and discussion partner to R&D, QA, Product Management and other functions and regions.
* Participate in project teams as regulatory support expert.
* Respond to regulatory-based issues promptly, including investigations, preparations and delivery of certificates, and use of internal/external databases.
* File and maintain complete documentation of questions and answers in databases; prepare, update and review regulatory support documentation (e.g., RSF, VG, VSF, CCN, statements, certificates) for new and existing products.
Requirements
* Bachelor of Science degree in Chemistry, Pharmacy or related field.
* 5–10 years of experience in Quality Assurance, Regulatory, or Product Management.
* Good understanding of GMP and regulatory requirements in the bioprocess industry.
* Excellent communication skills and fluency in English (written and spoken).
Nice to have
* Experience in large matrix organizations.
* Fluency in the language of the country of employment.
* Experience in customer communication.
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.
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