Head QARA

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 IIII.
• Prepare, submit, and maintain regulatory filings: 510(k), PMA, CE Technical Files, Design Dossiers, EUDAMED, CDSCO, and other global submissions.
• Liaise with regulatory authorities (FDA, Notified Bodies, CDSCO, etc.) for submissions, approvals, and audits.
• Ensure compliance with EU MDR, US FDA 21 CFR Part 11/820, ISO Risk Management) and other country-specific regulations.
• Support clinical evaluation reports (CER), biocompatibility assessments, usability engineering, and device safety documentation.

Quality Assurance

• Manage and maintain the Quality Management System (QMS) in accordance with

ISO 13485, ISO 14971, IEC 62304, IEC 60601, and MDSAP requirements.

• Oversee supplier quality management, incoming inspection, process validation, and final release.
• Lead internal audits, external audits, and notified body inspections; ensure timely CAPA closure.
• Define and monitor KPIs for quality performance (complaints, NCs, CAPA trends, product recalls).
• Oversee risk management, FMEA, hazard analysis, and design control documentation.
• Ensure product labeling, IFUs, and packaging meet regulatory standards for disposables and electromechanical devices.

Team & Cross-Functional Collaboration

• Lead and mentor the RAQA team, fostering a culture of compliance and continuous improvement.
• Work closely with R&D, Manufacturing, Clinical, and Marketing teams to integrate regulatory and quality considerations into product development lifecycle.
• Drive training programs for employees on regulatory and quality requirements.

Qualifications & Skills

• Bachelors or Masters degree in Biomedical Engineering, Mechanical/Electronics Engineering, Life Sciences, or Regulatory Affairs.
• 8–12 years of experience in RA/QA roles within the medical device industry, with at least 3–5 years in endoscopy/urology or related surgical devices.
• Strong knowledge of EU MDR, US FDA 21 CFR, ISO 13485, ISO 14971, IEC 60601,

IEC 62304, and global medical device regulations.

• Demonstrated success in 510(k)/PMA submissions, CE marking, and international product registrations.
• Experience with disposable (catheters, consumables) and electromechanical devices (endoscopic cameras, light sources, insufflators, etc.).
• Hands-on experience with risk management, design controls, CAPA, and post- market surveillance (PMS, PSUR, vigilance reporting).
• Excellent communication and leadership skills; ability to interact with regulatory bodies, auditors, and cross-functional teams.

Key Competencies

• Regulatory Strategy & Execution
• Quality Systems Management
• Risk Management & Compliance
• Leadership & Team Development
• Strong Analytical & Documentation Skills
• Continuous Improvement Mindset

Mandatory experience  FDA( 510K)/CE ( EU MDR) filing and grant

for consumable device like Cathetor, Stents etc. ( preferable) , electromechanical device filing is desired  Class 1 /Class 2