Manager - Quality Assurance & Regulatory Affairs
FUNCTION:
Quality & Regulatory
LEVEL:
Manager
EXPERIENCE:
6-10 Years
ABOUT THE ROLE
We are looking for a driven Manager - Quality Assurance & Regulatory Affairs to own our quality management system and lead regulatory submissions in India and internationally. The right candidate brings solid CDSCO experience, a proactive approach to managing timelines and submissions, and the ability to work across multiple workstreams without losing rigor. You will work closely with R&D, manufacturing, and operations to embed quality and compliance at every stage of the product lifecycle.
KEY RESPONSIBILITIES
1. Regulatory Affairs - CDSCO & International
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Manage all CDSCO regulatory submissions end-to-end: new product registrations, renewals, amendments, and import licenses for Class B and Class C medical devices and IVDs.
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Liaise directly with CDSCO and other regulatory bodies to resolve queries, track approvals, and ensure no licenses lapse.
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Prepare and review technical dossiers and MDR 2017-compliant submission packages.
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Support CE IVD submissions under EU IVDR - including Technical Files, Performance Evaluation Reports (PER), and Notified Body coordination - where applicable.
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Support WHO Prequalification (WHO PQ) submissions for IVDs where applicable.
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Stay current on CDSCO regulations, MDR 2017 updates, EU IVDR, and WHO PQ requirements, assessing impact and driving timely implementation.
2. Quality Management System (QMS)
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Own, maintain, and continuously improve the ISO 13485-compliant QMS across the organization.
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Develop, review, and update SOPs, work instructions, and quality records.
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Ensure document control, change control, and records management processes are robust and audit-ready.
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Drive QMS awareness and training across departments.
3. Design Controls & Technical Files
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Collaborate with R&D to ensure design control procedures are followed throughout the product development lifecycle.
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Maintain Design History Files (DHF), Device Master Records (DMR), and Technical Files.
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Lead risk management activities in accordance with ISO 14971.
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Ensure product safety requirements are addressed in line with IEC 61010-1 (safety requirements for electrical equipment for measurement, control, and laboratory use) where applicable.
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Ensure validation activities (process, test method, software) are planned, executed, and documented to regulatory standards.
4. CAPA, Audits & Nonconformances
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Lead the CAPA process from root cause analysis through effectiveness verification and closure.
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Plan and conduct internal audits, supplier audits, and management reviews per the QMS schedule.
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Prepare for and manage regulatory inspections and notified body audits.
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Oversee nonconformance management, deviation handling, and complaint investigations.
5. Post-Market Surveillance (PMS)
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Establish and manage a PMS system to monitor product performance in the field.
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Oversee vigilance reporting, adverse event tracking, and field safety corrective actions (FSCAs).
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Analyze PMS data to identify trends and drive product and process improvements.
6. Team & Cross-functional Leadership
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Lead and mentor the QA/RA team, setting clear objectives and building a quality-first culture.
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Provide training and guidance to employees across departments on quality and regulatory requirements.
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Collaborate with manufacturing, supply chain, R&D, and commercial teams to ensure end-to-end compliance.
QUALIFICATIONS & EXPERIENCE
Education: Bachelor's or Master's degree in Biomedical Engineering, Life Sciences, Biotechnology, or a related discipline.
Experience: 6-10 years in Quality Assurance and/or Regulatory Affairs in the medical devices or IVD industry, with at least 2-3 years in a hands-on CDSCO submissions role.
CDSCO: Demonstrated experience managing CDSCO submissions end-to-end, including direct engagement with regulatory officers and familiarity with CDSCO's filing processes in practice.
CE IVD / WHO PQ: Hands-on experience with CE IVD technical documentation under EU IVDR (Technical Files, PER, Notified Body liaison) or WHO Prequalification submissions for IVDs is highly desirable.
QMS: Hands-on expertise with ISO 13485 implementation, maintenance, and internal auditing.
Design Controls: Experience with DHF/DMR maintenance, design control procedures, ISO 14971 risk management, and familiarity with IEC 61010-1 safety requirements for electrical/laboratory equipment.
Audits & CAPA: Proven track record leading CAPA processes, internal audits, and regulatory inspections.
Leadership: Experience managing or mentoring a small QA/RA team preferred.
SKILLS & COMPETENCIES
Competency
What We Expect
Regulatory
Deep working knowledge of CDSCO processes, MDR 2017, ISO 13485, and relevant safety standards including IEC 61010-1. Stays current on regulatory changes.
Proactiveness
Tracks deadlines independently, anticipates issues early, and drives submissions to closure without needing to be followed up with.
Works Under Pressure
Manages multiple parallel projects and submissions calmly
Attention to Detail
Precise and thorough in documentation, dossier preparation, and audit readiness.
Communication
Effective communicator with regulators, auditors, and cross-functional teams alike.
Ownership
Takes full accountability for outcomes across the quality and regulatory function.
PREFERRED CERTIFICATIONS
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RAC (Regulatory Affairs Certification)
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ISO 13485 Lead Auditor Certification
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CQE / CQM (ASQ) or equivalent quality certification
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EU IVDR / CE IVD regulatory training or Notified Body auditor certification
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WHO Prequalification training or prior involvement in a WHO PQ submission
