Siemens Healthcare BPharma & MPharma Regulatory Affairs Job
Siemens Healthcare Private Limited
About the Company: Siemens Healthcare Private Limited is an organization under Siemens Healthineers specializing in quality management for diagnostic imaging and therapy medical devices.
Job Posting: Regulatory Affairs Professional
Position Summary
Job ID: 409613
Company: Siemens Healthcare Private Limited
Organization: Siemens Healthineers
Job Family: Quality Management
Experience Level: Experienced Professional
Full Time / Part Time: Full-time
Remote vs Office: Office/Site Only
Contract Type: Permanent
Internal Title: Regulatory Affairs Professional
Position Summary
This position is primarily responsible to ensure pre market & post market compliance to Medical Device Rules(MDR) 2017 governed by Central Drug Standard Control Organization (CDSCO) & state FDA for SHPL’s diagnostic imaging & therapy medical devices to be sold in India.
This position will also ensure compliance to the applicable regulatory requirements for these devices in zone countries of Bangladesh, Sri Lanka, Nepal, Bhutan & Maldives.
Job Description
- Responsible to interact with local marketing, global RA teams & make applications, clarify to queries, following up with CDSCO for licenses of Medical devices regulated under Medical Device Rules 2017.
- Responsible to obtain new wholesale license of 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 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.
Experience and Qualification
The ideal candidate should have:
- BPharm/ MPharm/ BTech/ MTech/ BSC/ MSc with 3-6 years’ experience of pre-market & post-market regulatory work on compliance to Medical Device Rules (MDR) 2017, Drugs & Cosmetics Act & Rules governed by CDSCO & state FDA for diagnostic imaging & therapy medical devices including Software medical devices.
- Knowledge about Medical device regulations in EU & USA, Bangladesh, Sri Lanka.
- Good communication & interpersonal skills.
Keywords: Regulatory Affairs Professional, Quality Management, Medical Device Rules, CDSCO, State FDA, Diagnostic Imaging, Therapy Medical Devices. Siemens Healthcare BPharma & MPharma Regulatory Affairs Job. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
