Regulatory Affairs Professional

2 days ago

Gurgaon, India Siemens Healthineers Full time

**Internal Title**:Regulatory Affairs Professional

**External Title**:Deputy General Manager

**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 IVD devices & 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.
- 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.
- 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.

**Experience and Qualification**:

- BPharm/ MPharm/ BTech/ MTech/ BSC/ MSc with 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.

**Organization**: Siemens Healthineers

**Company**: Siemens Healthcare Private Limited

**Experience Level**: Mid-level Professional

**Full / Part time**: Full-time

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