Regulatory Affairs Principal

Radiometer; Sunnyvale (CA); On-site; USD 145,000 - 200,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) to eligible employees

Job summary

Cepheid, located in Sunnyvale, CA, seeks a Regulatory Affairs Principal to lead regulatory strategy for new product development. You will prepare submissions (US FDA, IVDR, WHO/PQ) and coordinate with cross‑functional teams to secure timely approvals for software and hardware solutions.

The role emphasizes cybersecurity, DBS tool experience, and providing clear regulatory plans for US and EU markets, with opportunities for growth within Danaher’s global ecosystem.

Qualifications

• Bachelor's degree or higher with 8+ years in regulatory affairs
• Master's degree with 6+ years in regulatory affairs
• Doctoral degree with 3+ years in regulatory affairs

Responsibilities

• Prepare regulatory submissions (US FDA, IVDR, WHO/PQ) for NPD projects.
• Lead regulatory strategy for software/hardware with cybersecurity considerations.
• Engage with health authorities to obtain product approvals and maintain compliance.
• Provide regulatory updates and communicate status to core teams.

Skills

Regulatory strategy

US FDA knowledge

EU IVDR knowledge

Cybersecurity awareness

Project collaboration

Education

Bachelor's degree in applicable field

Master's degree in applicable field

Doctoral degree in applicable field

Tools

PowerPoint

DBS tools

Job description

Role Overview

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cepheid, 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 Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you'll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world's most complex health challenges. Together, we bring MORE change to the world. Learn about the Danaher Business System which makes everything possible. The Regulatory Affairs Principal is responsible to serve as RA lead on New Product Development (NPD) core teams, working on medium to complicated instrument, software projects and/or system projects. This position is part of the Regulatory Affairs New Product Development department and will be located in Sunnyvale, CA and will be an onsite role. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.

Responsibilities

• Prepare regulatory submissions and interact cross-functionally to ensure on time delivery (OTD) of product launches.
• Interact with regulatory agencies/health authorities to resolve queries and to obtain product approvals with a focus on US and EU IVDR and WHO PQ submissions as required.
• Serves as representative to gather and interpret new and changed regulations and guidelines in US and EU, with focus on software and cybersecurity.
• Implements continuous improvements and efficiencies using DBS tools.

Requirements

• Bachelor's degree in applicable field with 8+ years of related work experience OR Master's degree in applicable field with 6+ years of related work experience OR Doctoral degree in applicable field with 3+ years of related work experience
• Serves as RA lead on new product (NPD) core teams including medium to complicated instrument or software projects and submissions (510(k), De Novo, Class A, B, C or D) and collaborate with assay teams.
• Uses extensive experience and regulatory intelligence information and product knowledge to develop regulatory strategy for software and hardware submissions, including software development, cybersecurity and EMC deliverables, that are in scope for the initial product launch (US, EU, WHO/PQ).
• Authors, prepare, and support regulatory submissions (US-FDA, IVDR, WHO/PQ) as required by project plan.
• Prepares formal written reports, PowerPoint presentations to communicate regulatory strategies and status.

Preferred Experience

• Actively participating in project core teams, developing regulatory plans and collaboratively achieving project goals and meet timelines.
• Compiling, preparing, reviewing, supporting, and submitting regulatory submissions including FDA pre-submissions, 510(k) ,PMA submissions, and EU Technical Documents that include software and hardware including cybersecurity deliverables.
• Critical review of software and hardware protocols, reports and deliverables to assess quality, clearly identify gaps, and provide mitigations and actions to core team.

Travel & Physical/Environment Requirements

Ability to travel as needed for training, agency meetings, or support at additional Cepheid sites as needed, approximately 15% travel.

Compensation & Benefits

The annual salary range for this role is $145,000 - 199,500. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. Bonus / Incentive Pay 15% of annual base salary This job is also eligible for bonus / incentive pay. This is the target earnings as % of base annual salary, subject to objective eligibility criteria and performance conditions as set out in the applicable scheme terms and conditions.

• Paid time off
• Medical/dental/vision insurance
• 401(k) to eligible employees

Equal Opportunity & Diversity Statement

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. The U.S. EEO posters are available here. For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click here. 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 [e-mail].

Corporate Culture & Additional Information

Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact. Please read our Applicant Data Privacy Notice carefully here.

For more information, visit www.danaher.com.