Regulatory Affairs Professional - #977991

Siemens


Date: 3 days ago
City: Gurgaon, Haryana
Contract type: Full time

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.

Qualification and Experience

BPharm/ M Pharm/ 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.

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