Quality Assurance & Regulatory Affairs Lead

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Reporting:

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Key Responsibilities

The Lead of Quality Assurance and Regulatory Affairs will be a senior leadership role reporting directly to the BU Head. This position is responsible for the strategic direction, oversight, and execution of all Quality Assurance (QA) and Regulatory Affairs (RA) functions across 3 BUs of Zydus Medtech, ensuring compliance with national and international standards, and supporting innovation and market expansion.

Strategic Leadership & Governance

• 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)

Personnel & Team Management

• Lead and mentor QA and RA teams, defining roles, responsibilities, and KPIs
• Conduct performance appraisals, training plans, and succession planning
• Promote a positive working environment and team collaboration
• Manage departmental budgets and resource allocation efficiently

Operational Excellence

• Oversee supplier qualification, audits, and performance monitoring
• Ensure compliance with customer-specific quality requirements and contract reviews
• Manage change control systems and ensure proper documentation and traceability
• Support R&D and product development teams from concept to launch
• Drive implementation of electronic QMS and digital transformation initiatives
• Manage post market / post launch regulatory and quality activities

Qualifications & Experience:

• 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