Description
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 NPD Regulatory Affairs Senior Specialist is responsible to serve as RA lead on New Product Development (NPD) core teams, working on medium to complicated instrument, software projects and/or system projects.
This position is part of the Regulatory Affairs New Product Development department and will be located at India Development Center. 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 coordinate cross‑functional regulatory deliverables to support on‑time product launch execution
+ Manage interactions with regulatory agencies and health authorities to resolve technical queries and secure product approvals, including US and EU IVDR and WHO PQ submissions
+ Monitor, interpret, and apply updated US and EU regulatory requirements and guidelines with emphasis on software and cybersecurity regulations
+ Serve as regulatory representative to evaluate and communicate impacts of new or revised regulations on product development and compliance activities
+ Implement continuous improvement initiatives using DBS tools to increase efficiency within regulatory operations
The essential requirements of the job include:
+ Bachelor’s degree in an applicable field with 5+ years of related experience, or Master’s degree with 3+ years, or Doctoral degree with 0–2 years of experience in regulated product development
+ Minimum 5 years serving as Regulatory Affairs lead for NPD core teams supporting medium to complex instrument or software projects and regulatory submissions including 510(k), De Novo, and EU Class A–D
+ Proven experience developing regulatory strategy and submission content for software and hardware products, including software development documentation, cybersecurity files, and EMC deliverables for US, EU, and WHO/PQ product launches
+ Demonstrated experience authoring, preparing, and supporting regulatory submissions for US‑FDA, IVDR, and WHO/PQ in alignment with project plans
+ Experience generating formal regulatory reports and technical PowerPoint presentations to communicate regulatory strategy, submission status, and project deliverables
It would be a plus if you also possess:
+ Actively participating in project core teams, developing regulatory plans and collaboratively achieving project goals and meet timelines.
+ Compiling, preparing, reviewing, supporting, and submitting regulatory submissions including FDA pre-submissions, 510(k),PMA submissions, and EU Technical Documents that include software and hardware including cybersecurity deliverables.
+ Critical review of software and hardware protocols, reports and deliverables to assess quality, clearly identify gaps, and provide mitigations and actions to core team.
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.
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
