6 Qara Jobs

Job Summary: An experienced Quality Assurance and Regulatory Affairs (QARA) professional specializing in Med Device software quality including Software as a Medical Device (SaMD). The ideal candidate will have 310 years of hands-on experience in regulatory strategy, quality systems, and compliance for digital health products and medical device software. This role is critical in ensuring our SaMD offerings meet global regulatory and quality standards across the product lifecycle. Key Responsibilities: Develop and execute regulatory strategies for medical devices including SaMD products across global markets (FDA, EU MDR, etc.). Ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485, ISO ...

Hiring for a ManagerQARA for a leading medical device company Experience -5-12yrs Location -Delhi/NCR Job Profile -Responsible for leading Regulatory and Quality activities in the India Subcontinent geography- India and neighboring countries. responsible for driving regulatory process and strategy pertaining to registration of Company products in India Subcontinent geography & maintain data for registered products. He/she participates in all activities relating to preparation, compilation, submission of dossiers and follow up to obtain approvals/renewals for products and its variations & line extension indications and labeling approvals of medical devices. He/ she will be responsible for int...

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...

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...

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...

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...