Regulatory Affairs Principal

Danaher • Sunnyvale, CA

13d

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 for serving as RA lead on New Product Development (NPD) core teams, working on medium to complicated assay, instrument, software projects and/or system projects. This position reports to the Director Regulatory Affairs, NPD and is part of the Regulatory Affairs New Product Development department located in Sunnyvale, CA. Remote work may be considered in certain situations. In this role, you will have the opportunity to: Prepare regulatory submissions and interact cross-functionally on new product core teams 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 the US and EU. Implements continuous improvements and efficiencies using DBS tools.

Requirements

• Bachelor’s degree in applicable fields (such as biological sciences, biomedical engineering, or chemistry) 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 assay, instrument or software projects and complies, prepares, reviews, and submits regulatory submissions (Pre-submissions, 510(k), De Novo, PMA, IVDR Class A, B, C or D or WHO PQ).
• Critical review of study protocols and reports to assess quality, clearly identify gaps, and provide mitigations.
• Actively participates in project core teams, developing regulatory strategy and plans and collaboratively achieving project goals and meeting timelines.
• Prepares formal written reports, PowerPoint presentations to communicate regulatory strategies and status.
• Potential travel either domestic or international may be required up to 25%.

Nice To Haves

• Uses extensive experience and regulatory intelligence information and product knowledge to develop regulatory strategy for submissions.
• Ensuring design controls are met.

Responsibilities

• Prepare regulatory submissions and interact cross-functionally on new product core teams 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 the US and EU.
• Implements continuous improvements and efficiencies using DBS tools.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees