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Regulatory Affairs Professional

Job Description

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 . 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

Location of Position : Gurgaon

Job Duties & Responsibilities :

  • To perform regulatory tasks as applicable to SHPL products pertaining to regulating authorities like BIS(Bureau of Indian Standards), WPC( Wireless Planning & Coordination), TEC(Telecommunication Engg Center), MEITY(Ministry of Electronics & IT)

  • We need a Local technical expert on getting component certification process by following bodies such as

  •  BIS 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

  • Interact with local testing laboratories and get the components tested . 

  • Submit applications to approving bodies and get the components certified/licensed .

  • Responsible for product to qualify certification, apply registration, follow up for renewal, responsible for surveillance audit

  • Interact with global team for sample to be imported and to be tested

  • Responsible for In Vivo &In Vitro  company registration   .

Experience and Qualification :

Regulatory professional with 6-8 years experience of  dealing with above bodies .Candidate should have degree/diploma in electronics telecommunications or information technology .

Contact

If you have further questions regarding the  role then please be free to contact Pooja Kochar on pooja.kochar@siemens-healthineers.com .




Organization: Siemens Healthineers

Company: Siemens Healthcare Private Limited

Experience Level: Experienced Professional

Job Type: Full-time

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