Achira Labs is hiring for Manager - Quality Assurance & Regulatory Affairs

Medical Devices & IVD | Full-Time | India | Reports to: Head - QA/RA

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 rigour. 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

• 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 organisation.
• 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).
• Analyse 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

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

• 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