Head QARA (Sr Manager /DGM) For a leading Medical device Company Apogee Services

10.0 - 18.0 years

20 - 35 Lacs

gurugram

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Job Description: Head QARA Medical devices Location: Gurugram, India Job Overview The RAQA Manager will lead regulatory compliance and quality management activities for disposable and electromechanical devices used in endoscopy and urology , including Class I, Class II, and Class III medical devices . The role ensures adherence to global regulatory requirements (EU MDR, US FDA 21 CFR, ISO standards, etc.), oversees product registrations, and maintains robust quality systems aligned with ISO 13485 , IEC 60601 , IEC 62304 , and related standards. Key Responsibilities Regulatory Affairs Develop and implement regulatory strategies for new disposable and electro mechanical devices across Class II...

Posted 2 weeks ago

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Head QARA (Sr Manager /DGM) For a leading Medical device Company Apogee Services

10.0 - 18.0 years

20 - 35 Lacs

gurugram

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Posted 1 month ago

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QARA Engineer Larsen & Toubro (L&T)

5.0 - 10.0 years

0 - 1 Lacs

Bengaluru

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Job Title: QARA ENGINEER Experience: 4.5 to 10 years Location: Bangalore Mandatory Skill: US FDA, 510K, PMA, EU MDR, QARA. Regulatory gap assessment and remediation. Job Description: The objective of this project is to identify and remediate any deficiencies in the design history files (DHF) and device master records (DMR) of the stent graft integrated with 4 branched vascular prosthesis - FROZENIX 4 Branched, ensuring adherence to relevant standards, US Food and Drug Administration ("FDA") guidelines and regulations requirements by completing all necessary tasks including document translation (Japanese to English), gap assessment, remediation and submission query support. Design verificatio...

Posted 3 months ago

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