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 leads the governance, execution, and continuous improvement of regulatory data, systems, and business processes to ensure compliant product identification, registration, and release across global markets
.
The
Lead
Regulatory Affairs , Business Enablement Database
role
oversees regulatory modules within ERP systems (SAP) to control regulatory blocks, approvals, and order release, ensuring
on
‑
time
delivery to customers. Maintains
accurate
and auditable regulatory databases, including global registrations and listings (EUDAMED, PRRC, MHRA), and ensures completeness, accuracy, and traceability of regulatory records
in accordance with
QMS requirements.
This position
reports to the
On Market Sustainment Leader and
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:
Provides regional regulatory intelligence and
maintains
current regulatory listings (EUDAMED, PRRC, MHRA), ensuring alignment with evolving regulations and guidelines.
Manages and
maintains
regulatory data within SAP ERP, including regulatory blocks, releases, and
accurate
tracking of blocked/released products to support
timely
customer delivery.
Owns and supports regulatory databases and software tools (e.g., SAP, TrackWise, BI tools), including validation, documentation management, and registration tracking.
Drives continuous improvement initiatives using DBS tools, working
cross
‑
functionally
to enhance regulatory databases, reporting, and system efficiencies.
Ensures compliance with QMS requirements through
accurate
documentation, proper filing, SOP maintenance, standard work execution, and data completeness reviews.
The essential requirements of the job include:
Bachelor's degree in field with 5+ years of related work experience
or
Master's
degree in field with 3+ years of related work experience
Demonstrated experience managing regulatory data and listings within enterprise systems (e.g., SAP ERP) including regulatory blocks, releases, and product compliance tracking.
Ability to interpret and apply global regulatory requirements (EU MDR, IVDR, FDA, Health Canada, PMDA, etc.)
Familiarity with global regulatory frameworks and product registration processes within IVD diagnostics.
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
.
