Career for Regulatory Affairs Professional requires at Siemens | B.Pharm, M.Pharm
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, Siemens healthineers is championing new business models that maximize opportunity and minimize risk for healthcare providers.
Post : Regulatory Affairs Professional
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.
• 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.
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.
Experience : 8-10 Years
Qualification : B.Pharm, M.Pharm
Location : Gurugram
Industry Type : Pharma / Healthcare
Functional Area : Quality Management
End Date : 25th September, 2020
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