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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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