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

Location: Gurugram,

Job

disposable and electromechanical devices

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 14971 (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

• 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

• 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