Regulatory Affairs Principal

Cepheid; 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)

Job summary

Cepheid, a Danaher company in Sunnyvale, CA, seeks a Regulatory Affairs Principal to lead regulatory efforts on New Product Development, focusing on software and hardware with emphasis on cybersecurity. You will interact with US/EU authorities, drive submissions, and shape strategies for product launches.

The role requires a strong background in regulatory leadership, cross-functional collaboration, and extensive experience with FDA/IVDR/WHO PQ submissions, plus DBS process familiarity.

Qualifications

• Lead regulatory affairs on NPD core teams for medium to complex instrument or software projects.
• Develop regulatory strategy for software and hardware including cybersecurity deliverables.
• Prepare regulatory submissions (US-FDA, IVDR, WHO/PQ) per project plan.

Responsibilities

• Lead RA on NPD core teams including medium to complex instrument/software projects.
• Develop regulatory strategy for software/hardware including cybersecurity and EMC.
• Prepare formal regulatory submissions (FDA, IVDR, WHO/PQ) as required.

Skills

RA leadership

Regulatory strategy

FDA submissions

Cybersecurity

Software regulation

Education

Bachelor’s degree in applicable field

Master’s degree in applicable field

Doctoral degree in applicable field

Job description

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

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.

In This Role, You Will Have The Opportunity To

• 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.

The Essential Requirements Of The Job Include

• 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.

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

• 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, Motor Vehicle Record & Physical/Environment Requirements

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

Cepheid, 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.

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.

• 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.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

For more information, visit www.danaher.com.

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.

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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].