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, 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

Location: Gurgaon

Job Duties & Responsibilities :

This position is primarily responsible to ensure pre market & post market compliance to Medical Device Rules(MDR) 2018 governed by Central Drug Standard Control Organization (CDSCO) for SHPL's  IVD & other medical devices to be sold in India.

To take care of pre and post market regulatory submissions for IVD and medical devices as per MDR 2018 and MvPI.

-Plans and prepares product related submissions with Siemens internal (e.g. Regional Units) or external organizations according to regulatory requirements.

-Submits required documentation/information to local authorities or Siemens internal.

-Initiates and escalates necessary activities if deviations are identified.

-Ensures creation of adequate documentation for audits/inspections.

-Performs training within the organization in country specific regulatory requirements, if applicable.

Experience and Qualification :

Regulatory professional– 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.

Job ID: 190979

Organization: Siemens Healthineers

Company: Siemens Healthcare Private Limited

Experience Level: Experienced Professional

Job Type: Full-time

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