Regulatory Affairs Principal at Danaher

Bring more to life.Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnologyAt Cepheid one of Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers 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 youll 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 worlds 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.The essential requirements of the job include:Bachelors degree in applicable fields (such as biological sciences biomedical engineering or chemistry) with 8 years of related work experience OR Masters degree in applicable field with 6 years of related work experience OR Doctoral degree in applicable field with 3 years of related work experienceServes 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.Travel Motor Vehicle Record & Physical/Environment Requirements: Potential travel either domestic or international may be required up to 25%.It would be a plus if you also possess previous experience in:Uses extensive experience and regulatory intelligence information and product knowledge to develop regulatory strategy for submissions.Ensuring design controls are met.Cepheid a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at .The annual salary range for this role is $135000 - 190000. 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 job is also eligible for bonus/incentive pay.We offer a 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 Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.#LI-LCSJoin our winning team today. Together well accelerate the real-life impact of tomorrows 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 . 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- or . Key Skills Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills Employment Type : Full-Time Experience: years Vacancy: 1 Monthly Salary Salary: 135000 - 190000