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.
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The Regulatory Affairs Senior Specialist is responsible for leading and executing regulatory project submissions and license management for high-growth markets within the region, drive continuous improvements and contribute to the success of the business for the organization. In Cepheid, learn about the available training opportunities for career growth and development, but also on personal learning available within Danaher Business system.
This position is part of the Regulatory Affairs - Global Market Expansion Team and will be located in Sunnyvale, California, USA (Hybrid). At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.
In this role, you will have the opportunity to:
- Serves as the Regulatory Affairs (RA) lead on global Market Expansion registrations for simple to medium complicated projects for initial product approvals and renewals, for assays, instruments or software, in global Eastern Europe regions outside the EU to ensure OTD product launches.
- Prepares the regulatory strategy and submissions and interacts cross-functionally to ensure OTD product registrations. Interacts with regulatory agencies/health authorities to resolve queries and to obtain and maintain product approvals globally.
- Serves as RA representative to gather and interpret new and changed regulations and guidelines. Implements continuous improvements and efficiencies using DBS tools.
- Solves complex problems; takes a new perspective on existing solutions; exercises judgment based on the analysis of multiple sources of information.
- Uses knowledge of regulations and develops regulatory strategy for introducing new products to global regions to meet business priorities.
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
- Ability to work independently and maintain a "focused urgency" throughout the submission process.
- Strong written and communication skills, and comfortable to work in a dynamic multi-functional environment.
- Well versed in MS office and applications.
It would be a plus if you also possess previous experience in:
- Preference for familiarity with molecular science, or Polymerase Chain Reaction (PCR) based technology, or in diagnostics product development.
- Technical or operational related departments within an IVD or medical device industry is highly preferred.
- Regulatory knowledge and/or work experience with product submissions in regulated Commonwealth of Independent States and Balkan State countries.
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 .
At Cepheid we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part of the time at the Company location identified above and part of the time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cepheid can provide.
The salary range for this role is $103,000 - $160,000 USD. 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. We may ultimately pay more or less than the posted range. 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.
At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. 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. 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.
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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 to request accommodation.