Regulatory Affairs Principal

Danaher•Sunnyvale, CA

3d•$145,000 - $199,500•Onsite

About The Position

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.

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.

Nice To Haves

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.

Responsibilities

Serve as RA lead on New Product Development (NPD) core teams, working on medium to complicated instrument, software projects and/or system projects.
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.