Senior Manager, Customer Regulatory Support

Senior Manager, Customer Regulatory Support

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.

The Senior Manager, Customer Regulatory Support is responsible for guiding direct reports and the business in a global environment to set the strategy and operational approach for Cytiva. The senior manager will lead a team that is providing guidance to other Cytiva functions and associates involved in product development, lifecycle management, manufacturing, and quality assurance regarding applicable customer regulatory requirements and customer expectations on our products, processes, and documentation to ensure market access for Cytiva products.

This position reports to the Department Director for Regulatory Care and is part of the Customer Regulatory Support team within QARA located in Marlborough, MA or Uppsala, Sweden and will be an on-site role.

What you will do:

• Lead direct reports to set and maintain standards, and in providing customer facing regulatory support documentation, including change control notifications (CCNs), ensuring customer satisfaction and protection of Cytiva Intellectual Property.
• Provide guidance to other relevant Cytiva functions regarding customer expectations and required information and standards.
• Lead and set the direction for the team, individual contributors and direct reports.
• Contribute to the strategy and operational plan for the department in close collaboration with other critical functions in Cytiva
• Develop people, organization, and operating mechanisms to successfully meet customer expectations and requirements of Cytiva internal stakeholders.
• Identify and lead cross functional activities, including developing internal and external documentation to align with industry developments and enhanced customer expectations

Who you are:

• Bachelor's degree in a science/engineering or related field required, advanced degree beneficial
• Minimum 5-7 years' experience in product management, product support, or quality in a life sciences company
• Understanding of relevant regulatory, quality and scientific fundamentals applicable to Bioprocess products
• Demonstrated ability to balance resources, timing and quality of outcomes
• Proven leadership and change management skills
• Driven with experience leading cross-functional activities across global teams
• Strong written and verbal communication skills, fluent in English

Travel, Motor Vehicle Record & Physical/Environment Requirements: if applicable for role

• Ability to travel – opportunities for occasional international travel

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

• Managing a global cross functional team

Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job.

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.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: 1-202-419-7762 or applyassistance@danaher.com.