QA/RA Manager at Hunarstreet Technologies Pvt Ltd · Delhi, Gurugram, Noida, Ghaziabad, Faridabad · 5 - 8 years · ₹5L - ₹10L / yr · Profitable · Posted 29 Jul 2026
Responsibilities
• Manage the QA/RA team
• Author and refine procedures, instructions, templates, and our quality manual to maintain quality management standards
• Maintain and monitor our quality system within the company: changes, CAPA, Non conformities, Complaints, PMS, continuous improvement, trend analysis, etc.
• Train all employees to the QMS, and assess skills, knowledge and QMS application.
• Perform internal audits to assess the company compliance with our QMS.
• Contribute to maintaining quality system related documentation including supplier records, audits, purchase and manufacturing batch information.
• Work with our Notified Body to maintain current certifications and achieve award of a CE mark and FDA approval on new products.
• Build knowledge and maintain surveillance of the many relevant quality standards
• Provide technical support and resolve quality issues with suppliers, customers or auditors including introduction of new or re-designed components and processes.
• Present technical data to internal / external audit and inspection groups as required.
Requirements
• Minimum of 5 years of Medical device QA/RA experience
• In depth familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management.
• Quality Management experience in a manufacturing/production environment.
• Conscientious and responsible
• A keen eye for detail and a results driven approach
• Strong communication and presentation skills.
• Excellent organizational and leadership skills
• Proficient in MS Office
• In depth understanding of quality control procedures and relevant legal standards
• Excellent math abilities and working knowledge of data analysis/statistical methods
Shubham Vishwakarma
Full Stack Developer - Averlon
About Hunarstreet Technologies Pvt Ltd
About
At Hunarstreet Technologies Pvt Ltd, we specialize in delivering India’s fastest hiring solutions, tailored to meet the unique needs of businesses across various industries. Our mission is to connect companies with exceptional talent, enabling them to achieve their growth and operational goals swiftly and efficiently.
We are able to achieve a success rate of 87% in relevancy of candidates to the job position and 62% success rate in closing positions shared with us.
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20RA Lead (7–8 years) | EU MDR + India (CDSCO) | Medical Devices
Role summary
Lead regulatory strategy and submissions for a medical device portfolio (hardware + software + accessories) across the EU MDR and India (CDSCO), with strong ownership of technical documentation and lifecycle change management.
Key responsibilities
- Own regulatory strategy and submission planning for EU MDR + India; build timelines, evidence plans, and dossier readiness trackers.
- Lead/author EU MDR Technical Documentation (Annex II & III): device description, GSPR checklist, risk/benefit, V&V summaries, clinical evaluation linkage, labeling/IFU, PMS/PMCF plans.
- Drive classification and portfolio mapping; support UDI basics and EMDN/basic UDI alignment (as applicable).
- Manage Notified Body interactions: questions, responses, meeting preparation, evidence packaging, and change justifications.
- Own India lifecycle activities: CDSCO changes (PAC), license maintenance, and regulatory communications.
- Ensure regulatory alignment for standards-driven evidence: ISO 14971, IEC 62304, IEC 60601, IEC 81001-5-1, usability (IEC 62366-1), biocompatibility (ISO 10993), and sterilization/reprocessing (as applicable).
- Support labeling/claims governance: intended use, indications, contraindications, and marketing claims review.
- Build and mentor the RA team; ensure version control, traceability, and audit-ready submissions.
Must-have qualifications
- 7–8 years in regulatory affairs for medical devices (Class II/III exposure preferred).
- Strong experience with EU MDR technical documentation and handling Notified Body queries/submission packages.
- Working experience with the CDSCO regulatory lifecycle (licenses/changes) is strongly preferred.
- Solid understanding of standards-driven evidence for HW+SW devices (14971, 62304, 60601, usability, biocomp).
Nice to have
- Exposure to US FDA 510(k), clinical evaluation/PMCF, cybersecurity documentation, and SaMD claims strategy.
- Experience with complex HW+SW systems and regulated accessories/instruments.
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Full Stack Developer - Averlon