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 .
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 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, registration 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.
If you have further questions regarding the role then please be free to contact Pooja Kochar on email@example.com .
Organization: Siemens Healthineers
Company: Siemens Healthcare Private Limited
Experience Level: Experienced Professional
Job Type: Full-time