Siemens
Healthcare Private Limited Regulatory Affairs Professional B-Pharm/ M-Pharm
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A leader in
medical technology, Siemens Healthineers is constantly innovating its portfolio
of products and services in its core areas of diagnostic imaging, Advanced
Therapy, Diagnostic which includes Point of Care, Ultra Sound and many more.
Siemens Healthineers
is also actively developing its digital health services and enterprise services
to help customers succeed in today's dynamic healthcare marketplace . We are
championing new business models that maximize opportunity and minimize risk for
healthcare providers. We invite all those applicants who want to be part of
this exciting journey of Siemens
Healthcare .
Job Duties
& Responsibilities :
This position
is primarily responsible to ensure pre market & post market compliance to
Medical Device Rules(MDR) 2017 governed by Central Drug Standard Control
Organization (CDSCO) for SHPL's IVD
& other medical devices to be sold in India.
Job
Description
Responsible
for making applications, clarifying to queries, registeration of products
following up
with CDSCO for import license of IVD devices and medical devices regulated
under medical device Rules 2017.
following up
with CS team to get the field safety corrective actions implemented for
healthineers products.
Getting the
product change notifications implemented for healthcare diagnostics products.
Performing
quality system audits of suppliers and business partners. Supporting zone
countries like Bangladesh, Sri Lanka, Nepal & Maldives for regulatory
requirements related to IVD products.
Knowledge
of regulatory practices related to
manufacturing of IVD and medical devices .
Experience
and Qualification :
Regulatory
professional (General Manager) – B-Pharm/ M-Pharm with 8-10 years experience of
pre market & post market work on compliance to Medical Device Rules(MDR)
2017 governed by Central Drug Standard Control Organization (CDSCO) for SHPL's IVD & other medical devices.
Contact
If you have
further questions regarding the role
then please be free to contact Pooja Kochar on pooja.kochar@siemens-healthineers.com
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