Siemens Healthcare Pvt Ltd is hiring Regulatory Affairs Professional – B. Pharm/ M. Pharm/ B. Sc/ M. Sc can apply

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Are you a qualified B. Pharm, M. Pharm, B. Sc, or M. Sc professional seeking a dynamic career opportunity in regulatory affairs? Siemens Healthcare Private Limited is hiring a Regulatory Affairs Professional for the Gurugram region. Join our esteemed team and contribute to ensuring compliance and regulatory excellence in the healthcare sector. Apply now to advance your career with a leading global healthcare company committed to innovation and quality.

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Job Responsibilities:

• Responsible to interact with local marketing, global RA teams & make applications, clarify to queries, following up with CDSCO for licenses of IVD devices and medical devices regulated under Medical Device Rules 2017.
• Responsible to obtain new wholesale license of IVD devices & medical devices from state FDA, renew/amend existing license as required.
• Perform post market surveillance compliance & reporting for the registered devices.
• To evaluate, apply & get the Product Change Notifications approved for registered devices.
• Coordinate with CS & logistics team to get the Field Safety Corrective Actions implemented for devices.
• Support buss. partners in zone countries like Bangladesh, Sri Lanka, Nepal, Maldives & Bhutan to fulfill regulatory requirements related to IVD devices and Medical devices.
• Perform Quality system audits of suppliers, service agencies and business partners.
• Maintain documentation related to all above topics including progress & record trackers.
• Keep abreast on updates/ changes to applicable regulations & requirements for the devices and represent SHPL at industry forums on regulatory topics.

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MORE JOBS: Thermo Fisher Scientific is hiring Safety Specialist III – B. Pharma/ M. Pharma/ Pharma D/ B. Sc/ M. Sc can apply

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