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.
Position Regulatory Affairs Professional
Department Regulatory Affairs
Education B. Pharma/ M. Pharma/ B. Sc/ M. Sc
Experience 8-10 Years experience of pre-market & post market regulatory work on compliance to Medical Device Rules (MDR) 2017, Drugs & Cosmetics Act & Rules governed by Central Drug Standard Control Organization (CDSCO) & state FDA for IVD and medical devices. Should have knowledge about IVD devices & Medical device regulations in EU & USA, Bangladesh, Sri Lanka. Good communication & interpersonal skills.
Salary Competitive

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.
Job Location Gurugram
Job Type  Full Time
Category Quality Management
Organization Siemens Healthineers
Apply Onilne Click Here

 

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