Regulatory Affairs Role at Siemens Healthcare! Pharma Apply Now!
Regulatory Affairs Professional
Gurugram, Haryana, India
Job Description
Job ID: 427902
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
This position is primarily to support for ensuring pre-market & post-market regulatory compliances for import/manufacture of Diagnostics/In vitro devices (IVD) and Medical devices under Medical Device Rule 2017 and other applicable requirements in India. This position will also support in fulfilling the regulatory requirements for these devices in zone countries of Bangladesh, Sri Lanka, Nepal, Bhutan & Maldives.
Job Responsibilities:
- Responsible to interact with local marketing, global RA teams & make applications, clarify queries, and follow up with CDSCO for licenses of IVD devices and medical devices regulated under Medical Device Rules 2017.
- Responsible to obtain a new wholesale license of IVD devices & medical devices from state FDA, renew/amend existing licenses 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 business 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 of updates/changes to applicable regulations & requirements for the devices and represent SHPL at industry forums on regulatory topics.
Qualification and Experience
BPharm/M Pharm/BSc/MSc with 6 – 8 years of experience in 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.
Link to Original Notification to apply: Apply Here
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