Lead RA, Global QRC On-Market Sustainment

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 Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers 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 youll 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 worlds 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:
Lead cross functional regulatory engagement for global product lifecycle changes (specifically instrument and software changes) providing strategic guidance on implementation requirements regulatory risk and notifications to global authorities including BSI WHO and RoW Health Authorities.
Perform and deliver highly complex regulatory assessments for manufacturing facility product and packaging changes including review and approval of Agile AWF change orders and supporting documentation such as Technical Documentation updates or Letters to File.
Serve as a key regulatory business partner to manufacturing operations supply chain RA NPD and the Commercial QRA Center of Excellence to define data requirements submission strategies and regulatory priority plans.
Act as the Regulatory Affairs lead for compliance and QMS activities including internal external and customer audits; post market surveillance (PMS); nonconformances; CAPAs; and complaint investigations.
Drive on time delivery of regulatory strategies continuous improvement initiatives and regulatory intelligence through DBS tools while developing and maintaining position papers and reference libraries to support consistent global decision making.

The essential requirements of the job include:
Bachelors degree in a Life Science or related field 8 years experience in the IVD or Medical Device industry
Masters 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

Cepheida 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 atDanaher Benefits Info.

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.

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