Regulatory Affairs - Assistant Manager Syrma Johari Medtech

4.0 - 6.0 years

5 - 8 Lacs

jodhpur

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Role & responsibilities 1. Product Registration & Certification - Support in preparing the documentation or dossier as applicable for the product registration and the certifications. - Update the documents, for response to queries and other requirements as required by respective regulatory authorities in a stipulated time frame. 2. Regulatory Audits -Internal and External Audit - Provide assistance in Internal & External audits. - Draft, Internal audit reports and coordinate with auditors for the closure of audits in a timely manner - Assist with follow-up audits, as required. 3. QMS-Maintenance - Compile and maintain regulatory documentation databases as per ISO 13485:2016 and other applica...

Posted 5 hours 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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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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Sr. Manager QA&RA Laxmi Dental Export

10.0 - 12.0 years

15 - 20 Lacs

Mumbai Suburban, Mumbai (All Areas)

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Role & responsibilities Responsible for development, implementation, maintenance, and overall success of the companys quality and regulatory programs and strategies, including articulating quality standards and objectives, developing methods to embed quality into the product development and manufacturing processes, establishing vendor relationships and quality standards, and developing and implementing innovative programs to focus employees on improving product quality. Develop, implement, and support a comprehensive regulatory compliance strategy to meet global market requirements for our products and ensure alignment with our overall business strategy. Proactively partner with R&D, Marketi...

Posted 3 months ago

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