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Regulatory Affairs Associate

Regulatory Affairs Associate

2 - 5 years

|

0 Lacs

madurai tamil nadu india

Posted:9 hours ago| Platform:

Apply

Skills Required

documentation mdr assessment design reports communication

Work Mode

On-site

Job Type

Full Time

Job Description

Experience:

Education:

Quality Assurance

Skills & Requirements:

Regulatory Affairs

Strong knowledge of global regulatory frameworks: FDA QSR, ISO 13485, EU MDR, IEC standards
Experience in DHF assessment and remediation
Familiarity with FDA 21 CFR Part 820.30 and ISO 13485:2016 design control requirements
Documentation skills – validation reports, change control, deviation records
Strong communication skills, both written and verbal

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