Regulatory Affairs Principal

MedDeviceJobs; Sunnyvale (CA); On-site; USD 146,000 - 197,000; Full time

Benefits offered by this job

Bonus / incentive pay

Benefits package

Job summary

Cepheid, a Danaher operating company, is seeking a Regulatory Affairs Principal to lead regulatory efforts on NPD programs in Sunnyvale, CA. This on-site role collaborates with cross-functional teams to secure US FDA and EU IVDR approvals, including software and cybersecurity deliverables.

The role demands deep regulatory experience, the ability to build strategies, and interaction with health authorities across multiple regions. Travel ~15% may be required as projects demand.

Qualifications

• Bachelor’s degree with 8+ years of related work experience OR Master’s with 6+ years OR Doctoral with 3+ years.
• Leads on new product (NPD) core teams including medium to complicated instrument or software projects and submissions (510(k), De Novo, Class A–D).
• Develop regulatory strategy for software and hardware submissions including cybersecurity and EMC deliverables.
• Authors and supports regulatory submissions (US-FDA, IVDR, WHO/PQ) per project plan.

Responsibilities

• Prepare regulatory submissions and interact cross-functionally to ensure on time delivery of product launches.
• Interact with regulatory agencies to obtain product approvals with focus on US and EU IVDR and WHO PQ submissions.
• Represent to gather regulatory changes and interpret guidelines for US and EU, focusing on software and cybersecurity.
• Communicate regulatory strategies and status via formal reports and presentations.

Skills

Regulatory strategy

US FDA submissions

IVDR

US/EU regulatory submissions

Software regulatory

Cybersecurity regulatory

Regulatory intelligence

Cross-functional leadership

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?

At Cepheid, one of Danaher’s (https://danaher.com/our-businesses) 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 (https://www.danaher.com/how-we-work/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 (https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home) .

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.

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

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

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.

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 (http://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf) .

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 (https://jobs.danaher.com/global/en/notice-to-us-candidates-based-in/applying-for-roles-outside-nyc) .

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].

Operating Company: Cepheid