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Regulatory Affairs Professional

Job Description

Siemens Healthineers India is looking for a Regulatory Affairs Professional to handle the component registration and certification management of the medical X ray devices based out of its Bengaluru factory.

Roles and Responsibilities

You are responsible for the component registration and certification management of the XP global portfolio of medical X-ray products in order to comply to country regulations i.e India, China and Mexico. Further you are responsible for handling regulatory compliance/approvals with respect to accessories of 3rd party suppliers, thereby supporting the Siemens Healthineers global Accessories Solutions business.

In your role you assess and implement new and changed regulatory requirements together with R&D and the QT department and keep existing registrations up to date.

Keep a track on validity of the component and 3rd party product certificates and the renewal in respective countries.

Work in close coordination with the R&D, procurement, Quality teams, country representatives, and suppliers who handle certifications.

You maintain the approval status of components and 3rd party products in internal databases to ensure a smooth logistics process and to ensure compliance with regulatory requirements.

You align a common view on component registration requirements with other departments and business lines of Siemens Healthineers and support the implementation of these requirements in the processes of the X-Ray products business line.

Qualification/Experience/Skillset

o       Bachelor or Diploma Engineer in trade of Electronics/Electrical or Mechanical Engineering having 3-5 years of experience in R&D or Quality Assurance

o       Understanding the country regulation requirements for component registrations, i.e BIS in India.  Understanding of China (CCC) and Mexico (NOM) would be an advantage.

o       Solid knowledge of Quality standards and laws relevant in the medical device business (like EU-Medical Device Regulation, Medical Device Directive, ISO 9001, ISO 13485)

o       Process oriented, reliable and target oriented working, structured, able to analyze complex facts

o       MS Tools: Excel, MS Teams, Power Point, Outlook​

o       Experience with tool SAP P41​ would be an advantage




Organization: Siemens Healthineers

Company: Siemens Healthcare Private Limited

Experience Level: Early Professional

Job Type: Full-time

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