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Willware Technologies logo
Full Time - RA Specialist (3+ Years)-Onsite Willware Technologies

3.0 - 8.0 years

10 - 15 Lacs

indore, pune, mumbai (all areas)

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Company Name : Willware Technologies Work Model: Full Time (On-Site) Work Location: Pune Experience : 3 to 6 Years Role & responsibilities Regulatory Strategy : Develop strategies for market access and regulatory approvals. Regulatory Compliance : Ensure medical devices comply with EU MDR (2017/745) and other relevant regulations. Technical Documentation : Prepare and maintain Technical Files Regulatory Submissions: Handle CE Marking, Notified Body interactions, and EU registrations. Post-Market Surveillance: Adverse events, vigilance reporting, and Periodic Safety Update Reports (PSURs). Labeling & UDI Compliance: Ensure product labeling and Unique Device Identification (UDI) requirements a...

Posted 2 weeks ago

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