Manager – Regulatory Affairs & Quality Assurance (Gurgaon)
Location: Gurugram, Haryana, India (Hybrid)
Job ID: R0241066
Category: Regulatory Affairs / Quality Assurance
Industry: Medical Devices & Healthcare
Experience Required: Minimum 8+ years in Medical Device or Healthcare Industry
About the Organization
A globally recognized leader in kidney care and medical technology is seeking a seasoned regulatory professional to join its Systems, Quality & Regulatory (SQR) function. The organization operates across the full healthcare value chain, delivering innovative medical products, therapies, and digital health solutions while maintaining the highest standards of patient safety, regulatory compliance, and quality governance.
The SQR department ensures end-to-end regulatory compliance and quality excellence throughout the product lifecycle, supporting market access, manufacturing, supply chain operations, and post-market surveillance across global markets.
Role Summary
The Manager – Regulatory Affairs & Quality Assurance will lead regulatory strategy and quality compliance activities for medical devices and pharmaceutical products across the South Asia region. The role encompasses product registrations, lifecycle management, pharmacovigilance, post-market surveillance, audit readiness, distributor compliance, and Quality Management System implementation.
This position requires deep expertise in CDSCO regulations, medical device registrations, health authority negotiations, and regional regulatory frameworks to ensure uninterrupted market supply and full compliance.
Key Responsibilities
Regulatory Strategy & Product Registration
Lead medical device and drug registrations with CDSCO, State FDA, and relevant government authorities.
Develop and execute regulatory submission plans, including renewals, variations, and notifications.
Maintain up-to-date technical files, registration dossiers, and regulatory documentation.
Update Regulatory Information Management Systems (RIMS) and Global Regulatory Roadmaps with current registration status.
Liaise with health authorities during development, registration, and lifecycle management to resolve regulatory issues and secure approvals.
Quality Management & Compliance Oversight
Implement and maintain Quality Management Systems aligned with ISO 9001, ISO 13485, GMP, and GDP standards.
Ensure labeling and redressing activities comply with Good Manufacturing Practice requirements.
Monitor regulatory compliance of distributors and critical suppliers across the region.
Ensure compliant release and distribution of imported and marketed products under GDP guidelines.
Manage MRP implementation and NPPA compliance activities.
Pharmacovigilance & Post-Market Surveillance
Fulfil PVRP / Deputy PVRP responsibilities including PSUR submissions, Risk Management Plans (RMP), PV audits, and SOP implementation.
Manage adverse event and medical device incident reporting in accordance with local regulations and corporate policies.
Oversee product complaints, regulatory conformity assessments, and post-market safety systems.
Audit & Inspection Readiness
Ensure preparedness for internal and external audits and regulatory inspections.
Drive corrective and preventive actions (CAPA) for deviations and non-conformities.
Participate in regional Quality and Regulatory meetings to provide compliance updates and risk insights.
Cross-Functional & Stakeholder Management
Collaborate with Regulatory Affairs, Manufacturing & Supply Chain Quality, Commercial Operations, Technical Operations, Legal, Compliance, Marketing, and Sales teams.
Maintain professional relationships with regulatory agencies, distributors, customers, and third-party manufacturers.
Provide timely communication on regulatory risks, strategy, and portfolio impact to internal stakeholders.
Support import/export regulatory processes and tender submissions.
Educational Qualifications
Degree in Pharmacy, Chemical Engineering, Bioengineering, or Health Sciences.
Master’s degree in Regulatory Affairs, Quality, Science, or Pharmacy preferred.
Professional Experience
Minimum 8 years of industrial experience in the Medical Device or Healthcare Industry.
Strong engagement experience with Health Authorities across South Asia.
Proven expertise in medical device and pharmaceutical registrations.
Extensive experience negotiating with regulatory agencies.
Comprehensive knowledge of regional regulatory frameworks and compliance standards.
Technical & Functional Knowledge
Strong understanding of local regulatory laws across South Asia.
Working knowledge of ISO 9001, ISO 13485, GMP, GDP; ISO 31000 knowledge is desirable.
Familiarity with Regulatory Intelligence systems and RIMS platforms.
High proficiency in MS Office and adaptability to digital regulatory systems.
Desirable exposure to MedTech regulatory environments.
Core Competencies
Strong stakeholder management and cross-functional collaboration skills.
Excellent written and verbal communication skills in English.
Strong negotiation and interpersonal skills.
Ability to plan, prioritize, and align regulatory strategies with business objectives.
Solution-oriented mindset with the ability to manage multiple regulatory priorities.
Ability to work independently with minimal supervision while ensuring compliance excellence.
Reporting Structure
Reports to: Regional / Global Regulatory & Quality Leadership
Direct Reports: None
This role offers significant exposure to regulatory leadership, medical device compliance, pharmacovigilance oversight, and strategic quality governance within a global healthcare organization.
Apply now through ThePharmaDaily.com to advance your career in Regulatory Affairs, Medical Device Compliance, and Global Quality Assurance Leadership.
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