Regulatory Affairs Principal
Regulatory Affairs Principal
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$ 143400 - 197100
1 Vacancy
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 worlds 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 were working at the pace of change on diagnostic tools that address the worlds biggest health challenges driven by knowing that behind every test there is a patient waiting.
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 is part of the Regulatory Affairs New Product Development department and will be located in Sunnyvale CA. At Cepheid our vision is to be the leading provider of seamlessly connected diagnostic solutions.
In this role you will have the opportunity to:
Prepare regulatory submissions and interacts cross-functionally 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 experience
Serves as RA lead on new product (NPD) core teams including medium to complicated assay instrument or software projects and submissions (510(k) De Novo Class A B C or D).
Uses extensive experience and regulatory intelligence information and product knowledge to develop regulatory strategy for submissions that are in scope for the initial product launch (US EU WHO/PQ).
Authors and prepare regulatory submissions (US-FDA IVDR WHO/PQ) as required by project plan.
Prepares formal written reports PowerPoint presentations to communicate regulatory strategies and status.
It would be a plus if you also possess previous experience in:
Actively participating in project core teams developing regulatory plans and collaboratively achieving project goals and meeting timelines.
Compiling preparing reviewing and submitting regulatory submissions including FDA pre-submissions 510(k) and PMA submissions.
Critical review of study protocols and reports to assess quality clearly identify gaps and provide mitigations.
Travel Requirements:
Potential travel either domestic or international may be required up to 25%.
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 salary range for this role is $. 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 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.
Join 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. 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.
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.
Employment Type
Full-Time
