Regulatory Affairs Senior Specialist, New Product Development

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 Senior Specialist serves as the RA lead on New Product Development (NPD) core teams working on simple to medium complicated assay, instrument, software projects and/or system projects. This individual prepares the regulatory submissions and interacts cross-functionally to ensure on-time delivery (OTD) of product launches. This role offers exposure to diverse products and projects, DBS tools to implement continuous improvement, and drives introduction of new product availability while enhancing career growth within Regulatory Affairs. The position reports to the Manager, Regulatory Affairs, and is part of the New Product Development (NPD) team located remotely with primary Core Teams in Sunnyvale, CA USA or Solna, Sweden. In this role you will have the opportunity to:

• Identify key regulatory submission deliverables and contribute to the development of a project master schedule
• Prepare regulatory submissions including formal written technical reports
• Provide regulatory leadership to new product development teams to advise on impact of product or business decisions.
• Provide regulatory training to cross-functional groups
• Actively manage and monitor submissions under review. Respond promptly and negotiate with regulatory authorities, as needed. Track and manage regulatory review timelines

The essential requirements of the job include:

• Bachelor’s degree in field with 5+ years of related work experience OR Master's degree in field with 3+ years of related work experience OR Doctoral degree in field with 0-2 years of related work experience
• In depth understanding of Regulatory Affairs concepts and should be familiar with regulations/guidelines governing development of diagnostic products
• Experience supporting 510k submissions required, authoring compiling, preparing, reviewing, and submitting regulatory submissions including FDA pre-submissions, 510(k) via eCopy or eSTAR and PMA submissions preferred.
• Ability to prioritize, multi-task, and organize work. Detail oriented with good analytical skills.
• Ability to succeed in a fast-paced environment with the ability to be flexible and adaptable within a dynamic environment

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

• Serving as a lead (full core team member) on project Core Teams
• Keeping abreast of changes of new or updated regulatory policies and issued guidance
• Critical review of study protocols and reports to assess quality, clearly identify gaps, and provide mitigations

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. At Cepheid we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cepheid can provide. ​ The annual salary range for this role is $92,500 - $127,500 . 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. Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. 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. 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 [email protected]. Apply tot his job Apply To this Job