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Regulatory Officer/Engineer at Shaily Innovations Ltd.

Vadodara, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

07 Apr, 26

Salary

0.0

Posted On

07 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Compliance, DMF Submission, Indian MDR, Regulatory Documentation, USP Testing, Biocompatibility Testing, Post Market Surveillance, Customer Query Resolution, Regulatory Agency Query Resolution, Audit Compliance

Industry

Description

- Regulatory Officer for Medical Devices - DMF submission for US, Health Canada, EU, India, China and other countries as per requirements - Indian MDR (CDSCO) license applications - Maintain regulatory documentation for all input materials received from suppliers - USP testing & Biocompatibility testing of products to maintain - Post Market Surveillance of products - Customer query to resolve for regulatory topics - Regulatory agency query to resolve - Audit compliance

Responsibilities

The Regulatory Officer will be responsible for DMF submissions for various countries and maintaining regulatory documentation for input materials. They will also handle post-market surveillance and resolve queries from customers and regulatory agencies.