Chief Quality Assurance and Regulatory Affairs Professional

24 hours ago

Ahmedabad, Gujarat, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

Overview

The Lead of Quality Assurance and Regulatory Affairs is a senior leadership position responsible for the strategic direction, oversight, and execution of all Quality Assurance (QA) and Regulatory Affairs (RA) functions. This role ensures compliance with national and international standards and supports innovation and market expansion.

Key Responsibilities

  • Develop and implement QA and RA strategies aligned with business goals.
  • Lead cross-functional teams to ensure quality and regulatory compliance throughout the product lifecycle.
  • Represent the company in regulatory and quality discussions with external stakeholders, including regulatory bodies, partners, and auditors.
  • Provide regular updates and reports to the Leadership and Board on compliance status, risks, and strategic initiatives.

Quality Assurance

  • Oversee the Quality Management System (QMS) ensuring compliance with ISO 13485, GMP, GDP, GVP, and MDD/MDR standards.
  • Lead internal and external audits, inspections, and quality improvement initiatives.
  • Manage CAPA (Corrective and Preventive Actions), non-conformance, and complaint handling processes.
  • Ensure validation of equipment, processes, and software used in manufacturing and testing.
  • Supervise final batch release, documentation control, and production line clearance.
  • Champion continuous improvement initiatives and foster a culture of quality across the organization.

Regulatory Affairs

  • Develop and execute regulatory strategies for India and international markets (US FDA, EU MDR, etc.).
  • Ensure timely regulatory submissions, product registrations, and lifecycle management.
  • Maintain compliance with MAH requirements and marketing practices.
  • Lead regulatory due diligence for licensing, acquisitions, and partnerships.
  • Monitor and communicate changes in regulatory requirements to senior management.
  • Coordinate Medical Device Reporting (MDR), product recalls, and safety notifications.
  • Act as primary contact for correspondences, inquiries, inspections with external agencies (e.g. regulatory authorities).

Required Skills and Qualifications

  • Master's degree in Pharmacy, Chemistry, Biotechnology, Biomedical Engineering, or related field.
  • Minimum 15 years of experience in QA and RA, with at least 5 years in a leadership role in the medical device or pharmaceutical industry.
  • Proven expertise in ISO 13485, FDA 21 CFR Part 820, EU MDR, GMP, GDP, and GVP.
  • Experience in hosting and leading audits by regulatory authorities (FDA, CDSCO, EU Notified Bodies).
  • Strong project management, analytical, and problem-solving skills.
  • Excellent communication, interpersonal, and leadership abilities.
  • Proficiency in Microsoft Office and QMS software tools.
  • Regulatory Affairs Certification (RAC) or equivalent preferred.

Preferred Skills

  • Experience in regulatory submissions for clinical studies.
  • Certified Internal/External Auditor.
  • Exposure to Pharmacovigilance (GVP).
  • Implementation of electronic QMS platforms.
  • Strategic planning and risk mitigation capabilities.
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