Description
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 (https://danaher.com/our-businesses) 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 (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.
The Staff RA Engineer serves as RA lead on New Product Development (NPD) core teams, working on medium to complicated instrument, software projects, or system projects.
This position is part of the Regulatory Affairs department and will be located in India. 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 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.
+ Provided guidance on safety and regulatory matters throughout the design, manufacturing, and inspection processes, ensuring international market approvals.
+ Serves as representative to gather and interpret new and changed regulations and guidelines in US and EU.
+ Implements continuous improvements and efficiencies using DBS tools.
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
+ Serves as RA lead on new product (NPD) core teams including medium to complicated instrument, software projects, systems and submissions (510(k), De Novo, Class 1, 2 & 3).
+ Possesses a high level of technical understanding of hardware, software, wireless connectivity, and safety guidelines and regulations such and RoHS, REACH, and EMC testing requirements.
+ 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.
It would be a plus if you also possess previous experience in:
+ 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.
+ Experience with HW and SW testing including EMC and safety testing.
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 (https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home) .
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 .
Operating Company: Cepheid
