Achira Labs Pvt. Ltd.
Website:
achiralabs.com
Job details:
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.
Role: Manager - Quality Assurance & Regulatory Affairs
Medical Devices & IVD | Full-Time | India | Reports to: Head - QA/RA
EXPERIENCE:5+ years
KEY RESPONSIBILITIES
1. Regulatory Affairs - CDSCO & International
- 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.
- Liaise directly with CDSCO and other regulatory bodies to resolve queries, track approvals, and ensure no licenses lapse.
- Prepare and review technical dossiers and MDR 2017-compliant submission packages.
- Support CE IVD submissions under EU IVDR - including Technical Files, Performance Evaluation Reports (PER), and Notified Body coordination - where applicable.
- Support WHO Prequalification (WHO PQ) submissions for IVDs where applicable.
- 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)
- Own, maintain, and continuously improve the ISO 13485-compliant QMS across the organization.
- Develop, review, and update SOPs, work instructions, and quality records.
- Ensure document control, change control, and records management processes are robust and audit-ready.
- Drive QMS awareness and training across departments.
3. Design Controls & Technical Files
- Collaborate with R&D to ensure design control procedures are followed throughout the product development lifecycle.
- Maintain Design History Files (DHF), Device Master Records (DMR), and Technical Files.
- Lead risk management activities in accordance with ISO 14971.
- 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.
- Ensure validation activities (process, test method, software) are planned, executed, and documented to regulatory standards.
4. CAPA, Audits & Nonconformances
- Lead the CAPA process from root cause analysis through effectiveness verification and closure.
- Plan and conduct internal audits, supplier audits, and management reviews per the QMS schedule.
- Prepare for and manage regulatory inspections and notified body audits.
- Oversee nonconformance management, deviation handling, and complaint investigations.
5. Post-Market Surveillance (PMS)
- Establish and manage a PMS system to monitor product performance in the field.
- Oversee vigilance reporting, adverse event tracking, and field safety corrective actions (FSCAs).
- Analyze PMS data to identify trends and drive product and process improvements.
6. Team & Cross-functional Leadership
- Lead and mentor the QA/RA team, setting clear objectives and building a quality-first culture.
- Provide training and guidance to employees across departments on quality and regulatory requirements.
- 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
CompetencyWhat We ExpectRegulatory: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
- RAC (Regulatory Affairs Certification)
- ISO 13485 Lead Auditor Certification
- CQE / CQM (ASQ) or equivalent quality certification
- EU IVDR / CE IVD regulatory training or Notified Body auditor certification
- WHO Prequalification training or prior involvement in a WHO PQ submission
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