Principal Regulatory Affairs Specialist (Remote)

Company: Danaher Corporation
Location: Seattle
Posted on: September 24, 2022

Job Description:

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we're working at the pace of change on diagnostic tools that address the world's biggest health challenges, driven by knowing that behind every test there is a patient waiting.Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.The Principal Regulatory Affairs Specialist works independently in preparing and managing regulatory submissions and interacts with regulatory agencies/health authorities/authorized representatives to obtain and maintain product approvals. Participate in regulatory intelligence groups and represent Regulatory Affairs on product life-cycle management teams as needed. Leads functional teams and/or projects. This position is part of the Global Regulatory Affairs department and will be located remotely.In this role, you will have the opportunity to:+ Interpret federal/state/international regulations as they apply to Cepheid products, processes and/or procedures.+ Advise on impact of regulations, devise strategies for compliance, and liaison with regulatory bodies. Investigate and resolves compliance problems, questions and complaints.+ Audit and evaluate current policies, procedures, and documentation for compliance with regulations and statutes.+ Actively participate in project core teams and strive to collaboratively achieve project goals and meet timelines+ Compile, prepare, review and actively manage and monitor submissions (FDA Pre Submission, 510K, IVDR Technical Documentations) 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 8+ years of related work experience OR Master's degree in field with 6+ years of related work experience OR Doctoral degree in field with 3+ years of related work experience+ In depth understanding of Regulatory Affairs concepts and should be familiar with regulations/guidelines governing development of diagnostic products+ Interact with global regulatory leaders and peers to expedite approval of pending registrations+ Actively manage and monitor submissions under review. Respond promptly and negotiate with regulatory authorities, as needed. Track and manage regulatory review timelines+ In depth understanding of Regulatory Affairs concepts and should be familiar with regulations/guidelines governing development of diagnostic products.It would be a plus if you also possess previous experience in:+ Partnering with Clinical Affairs and R in the development of clinical strategy and analytical plans respectively+ Formulating short-term planning for individual deliverables and participate in long term planning within the organization+ Provide regulatory training to cross-functional groupsCepheid, a Danaher 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.#LI-LH2When you join us, you'll also be joining Danaher's global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.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. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation. If you've ever wondered what's within you, there's no better time to find out.Operating Company: Cepheid

Keywords: Danaher Corporation, Seattle , Principal Regulatory Affairs Specialist (Remote), Other , Seattle, Washington