Who we are?
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, Siemens healthineers is 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 .
Please find more information on our organization at : https://www.healthcare.siemens.co.in/
We are looking forward to receiving your online application. Please ensure you complete all areas of the application form to the best of your ability as we will use the data to review your suitability for the role.
What is in for you?
Title – Regulatory Affair Professional
Job ID: 113737
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.
1. We are looking for regulatory expert on getting component certification process by following bodies such as
Bureau of India Standards
CRS Compulsory Registration Scheme for Electronics & IT goods
MeiTY Ministry of Electronics & Information Technology
MoEF Ministry of Environment & Forests
DoT Department of Telecommunication
WPC The Wireless Planning & Coordination, others and the applicable technical standards there in.
Technical understanding of electrical standards for the above regulations is must
2 .Interact with local testing laboratories and get the components tested .
3.Submit applications to approving bodies and get the components certified/licensed .
4. Responsible for product to qualify certification, apply registration, follow up for renewal, responsible for surveillance audit
5.Interact with global team for sample to be imported and to be tested
6, Responsible for In Vivo and In Vitro company registration .
Experience and Qualification :
Regulatory professional (PL7) – 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.
If you have further questions regarding the role thenplease be free to contact Pooja Kochar on firstname.lastname@example.org .
Job ID: 113737
Organization: Siemens Healthineers
Company: Siemens Healthcare Private Limited
Experience Level: Experienced Professional
Job Type: Full-time