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 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 which makes everything possible.
The QRC On-market Sustainment team creates the regulatory strategy and assessments for complex post market design changes; interfaces with global regulatory authorities including BSI and WHO; and collaborates cross functionally to assess regulatory risk, define data and submission requirements as a result of design changes.
The Lead RA, Global QRC On-market Sustainment role has primary responsibility to serve as RA lead on Project teams for product lifecycle management including completing highly complex assessments for notifying global regulatory agencies of product and facility changes. The Lead Regulatory Affairs serves as RA lead for QMS/Compliance activities requiring RA input, such as audits, PMS, NCs, CAPAs, Field Actions and complaints. They implement continuous improvements and efficiencies using DBS tools, mentor and coach others.
This position is part of the QRC On Market Sustainment team and will be located onsite in India.
In this role, you will have the opportunity to:
The essential requirements of the job include:
• Bachelor’s degree in a Life Science or related field + 8 years’ experience in the IVD or Medical Device industry
• Master’s degree in a Life Science or related field + 6 years’ experience in the IVD or Medical Device industry
• Familiarity with global regulatory frameworks and global product registration processes within IVD diagnostics.
• Reviews and interprets regulatory intelligence information. Shares RI with RA and other cross functional teams and provides training to other associates as needed.
• Solves complex problems; takes a new perspective using existing solutions.
It would be a plus if you also possess previous experience in: Familiarity with commercial product lifecycle strategies and market access planning
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.
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.