Website:
bgr-global.com
Job details:
Head – Quality & Regulatory Affairs
About the Opportunity
This is a strategic leadership appointment reporting directly to the Chairman & Managing Director – a rare opportunity to shape quality culture, build global regulatory frameworks, and drive operational excellence at an organisation scaling aggressively into regulated markets across USA, Europe, Japan, and China.
The Organisation
Products: Antigens, Antibodies, Diagnostic Kits
Certifications: EN ISO 13485, GMP Manufacturing
Global Footprint: Exports to USA, Europe, Japan, China
Location: Mumbai
The organisation is in a significant growth phase, expanding export operations into highly regulated markets. This creates an urgent need for a world-class quality and regulatory leader who can build systems, own compliance strategy, and represent the organisation to global regulatory authorities.
The Role
Position Details
Title: Head – Quality & Regulatory Affairs
Reporting to: Chairman & Managing Director (CMD)
Location: Mumbai
Travel: Occasional domestic and international travel
Compensation: ₹70-100 LPA++ (Competitive with market benchmarks)
Strategic Mandate
Build, lead, and institutionalise a robust Quality Management System (QMS) and global regulatory framework across products, plants, and markets – ensuring first-time-right quality and full compliance with ISO 13485, USFDA, WHO-PQ, and EU MDR/IVDR requirements.
This is NOT a compliance role – this is a quality transformation and regulatory strategy leadership role.
Key Accountabilities
Quality Management
- Establish and maintain a robust Quality Management System (QMS) compliant with ISO 13485, USFDA, WHO-PQ, and EU MDR/IVDR regulations
- Implement effective quality control processes throughout the manufacturing cycle – raw material inspection, production monitoring, and final product release
- Define and track key quality metrics (defect rates, customer complaints, non-conformance incidents) to drive continuous improvement
- Conduct regular internal audits and coordinate external audits by regulatory bodies and certification agencies
Regulatory Compliance
- Stay updated on the latest regulatory requirements and standards relevant in countries/regions where products are marketed
- Ensure timely submission of regulatory filings and documentation for new product registrations, variations, and renewals
- Establish processes for regulatory monitoring, tracking changes in regulations, and assessing impact on product compliance
- Work closely with cross-functional teams to ensure compliance with labeling requirements, post-market surveillance, adverse event reporting, and other regulatory obligations
Product Development and Lifecycle Management
- Collaborate with R&D and product development teams to ensure quality and regulatory considerations are integrated into the design and development of new testing kits
- Conduct risk assessments and implement risk management strategies throughout the product lifecycle
- Oversee validation and verification processes for new products or changes to existing products, ensuring adherence to applicable standards
- Develop and maintain technical documentation (product specifications, manufacturing instructions, product change control records)
Supplier Quality Management
- Establish supplier evaluation and qualification processes to ensure all purchased components and raw materials meet quality standards
- Conduct periodic audits and assessments of suppliers to monitor compliance with quality and regulatory requirements
- Foster strong relationships with suppliers, promoting collaboration and continuous improvement to enhance overall supply chain quality
Customer Satisfaction
- Define and monitor customer satisfaction metrics (product performance feedback, complaint resolution, on-time delivery)
- Implement processes to capture and address customer feedback, including complaint handling, investigation, and corrective/preventive actions
- Collaborate with customer support and sales teams to ensure customer expectations are met and regulatory obligations related to customer interactions are fulfilled
Continuous Improvement
- Drive a culture of continuous improvement across the organisation by promoting quality awareness, training, and knowledge sharing
- Implement Lean Six Sigma methodologies or other quality improvement approaches to optimize processes, reduce waste, and enhance efficiency
- Regularly review and update quality procedures, work instructions, and policies to align with industry best practices and regulatory changes
Ideal Candidate Profile
Educational Qualifications
Essential: Post Graduate (M.Sc. / M.Pharm) or equivalent, OR Ph.D. in Life Sciences or related discipline
Desirable: Management degree (MBA or equivalent)
Experience Requirements
Total Experience: 18–25 years in quality and regulatory functions
Leadership Experience: Minimum 5–8 years in functional leadership roles
Industry and Technical Requirements
- Experience in Medical Devices / Diagnostics or adjacent regulated manufacturing industries
- Proven experience in USFDA / WHO-PQ approved company environments
- ISO 13485:2016 hands-on ownership – not just exposure (Lead Auditor certification highly desirable)
- Built, led, and maintained a Quality Management System (QMS) end-to-end
- Experience in product registrations and regulatory filings in regulated markets (USA, EU, Japan, etc.)
- Expertise and experience in handling multiple products and sites
- In-depth knowledge of regulations in concerned markets (USFDA, EU MDR/IVDR, WHO-PQ, CDSCO)
- Excellent documentation and quality compliance capabilities
Leadership and Competencies
- Excellent leadership and people management skills – ability to lead and develop people
- Risk-taking and decision-making capabilities with strategic thinking
- Customer centricity and business partnering mindset
- Track record of driving results and achieving excellence
- Strong cross-functional collaboration and stakeholder management skills
What Makes This Role Compelling
Strategic Impact
- Report directly to the CMD – this is a trusted strategic partner role, not a functional compliance role
- Shape the organisation's quality culture for the next decade as it scales aggressively into regulated global markets
- Build and own regulatory strategy – not just manage compliance
- Represent the organisation to global regulatory authorities (USFDA, WHO, EMA, PMDA)
Growth and Scope
- Be part of an organisation scaling exports aggressively to USA, Europe, Japan – requiring regulatory leadership at the highest level
- Lead greenfield and brownfield projects – build systems from ground up
- Own quality and regulatory frameworks across multiple products, plants, and geographies
- Rare opportunity to integrate quality thinking into product development, manufacturing, and commercial operations
Professional Development
- Clear defined career path with opportunities to grow and excel within the organisation
- Exposure to complex global regulatory environments (USFDA, WHO-PQ, EU MDR/IVDR)
- Work in a science-driven organisation with strong R&D and innovation culture
- Collaborate with global regulators, certification bodies, and industry peers
Click on Apply to know more.