Danaher Corporation Quality Regulatory Support Manager in Marlborough, Massachusetts
Be part of something altogether life-changing.
Working at Cytiva in the Life Sciences industry 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. With associates across 40 countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.
Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
We are looking for a Regulatory Support Manager to work with our expert Customer Regulatory Support team of 17 employees across the world. Do you have a passion for BioProcess quality and compliance? Then we would love to hear from you.
What you’ll do
The Regulatory Support Manager will have responsibility for supporting Product Managers, Regions and customers by providing quality documents and regulatory support in response to customers' requests for quality, regulatory and technical-related information. Responsibilities will also include providing regulatory support in ongoing projects, product care activities, and change control.
Understand and maintain knowledge of BioProcess customers' regulatory requirements. Participate in creating and updating guidelines and steering documents to align. Act as regulatory support expert and discussion partner to R&D, QA, Product Management and other functions and regions.
Prepare, update and review regulatory support documentation, including Validation Guides, change control notifications, statements, certificates and other regulatory related documentation for new and existing products
Participate in change control activities, including writing and releasing formal change control notifications
Respond efficiently and promptly to customers' regulatory based issues, which will include necessary investigations, preparations and delivery of certificates and documentation, use of internal and external databases.
Who you are
Bachelor of Science degree in Chemistry, Pharmacy or related field
Three or more years of experience in quality, product management or a related field
Understanding of GMP and knowledge of regulatory requirements in the BioProcess industry
Organized, accurate, target oriented, quality minded and customer oriented
Strong written and verbal communication skills
Flexible and service-minded with the ability to be collaborative
Driven with strong ability to work independently
Who we are
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.
Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.
If you’ve ever wondered what’s within you, there’s no better time to find out.
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 (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .