Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Beckman Coulter Life Sciences, 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.
At Beckman Coulter Life Sciences, we know time is the most critical facet in the laboratory today: time to get life-saving therapies to patients faster; reclaiming time by automating tedious manual workflows; and saving time spent addressing erroneous or complex results.
We are partners in time and accelerate answers to critical questions through the power of automation. We develop innovations for scientists by scientists, with many of our 3,300+ global colleagues coming from the laboratory.
It’s all part of our time-tested approach to bringing meaningful innovations at the speed of life since 1935. And we’re just beginning. Working together, let’s put our time and talents together to advance human health for tomorrow.
Learn about the Danaher Business System which makes everything possible.
The Senior Analyst, Regulatory Affairs is responsible for supporting regulatory intelligence and regulatory change management activities to help maintain compliance with global regulatory requirements. This role monitors emerging regulations, assesses potential impacts on products and business processes, and partners with cross-functional teams to support timely implementation of compliance actions. The position contributes to regulatory compliance programs that minimize business disruption, regulatory risk, and potential delays to product commercialization and distribution.
This position reports to the Senior Manager, Regulatory Affairs and is part of the Global Quality & Regulatory Affairs organization and will be an on-site role.
In this role, you will have the opportunity to:
Monitor and track global regulatory developments affecting IVDs, medical devices, software, AI-enabled products, and chemical/environmental compliance frameworks (e.g., FDA, EU IVDR, REACH, RoHS, CLP, PFAS, EPA).
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Perform regulatory intelligence assessments and summarize regulatory changes, identifying potential impacts to products, processes, systems, and documentation. Maintain regulatory intelligence databases, dashboards, trackers, and communication tools.
Prepare regulatory impact assessments and support regulatory change management activities, including tracking actions, maintaining compliance plans, and facilitating implementation with cross-functional stakeholders. Develop and deliver periodic regulatory intelligence reports and presentations for management review.
Leverage digital and AI-enabled tools to improve regulatory monitoring, trend analysis, and knowledge management processes.
Support inspections, audits, and compliance initiatives by providing regulatory intelligence and change management documentation.
The essential requirements of the job include:
Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or a related field; Master's degree preferred. 5+ years of experience in Regulatory Affairs, Regulatory Intelligence, Quality, Compliance, or related functions within the medical device or IVD industry.
Working knowledge of global medical device and IVD regulations, including FDA regulations, EU IVDR, ISO 13485, and applicable regulatory guidance.
Experience conducting regulatory assessments and translating regulatory requirements into actionable business recommendations and managing or supporting compliance-related projects in a cross-functional environment.
Strong analytical, communication, and project management skills.
Experience using regulatory intelligence platforms, compliance databases, or digital tools.
It would be a plus if you also possess previous experience in:
Experience with AI/software regulations, cybersecurity regulations, or chemical/environmental compliance requirements.
Experience supporting audits, inspections, or interactions with regulatory authorities and notified bodies.
Experience leveraging AI or automation tools to improve regulatory intelligence workflows.
Beckman Coulter Life Sciences, 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. Check out our benefits at Danaher Benefits Info.
At Beckman Coulter Life Sciences we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Life Sciences can provide.
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.
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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