Regulatory Affairs & Quality Associate – Medical Devices Job in Bangalore at Ayu Devices

About the Job

We are looking for an experienced Regulatory Affairs & Quality Associate to lead and manage regulatory compliance and quality systems for medical devices across India and global markets. The candidate will be responsible for CDSCO registrations, ISO certifications, IEC compliance, EU MDR, and US FDA regulations, ensuring products meet all regulatory, safety, and quality requirements throughout their lifecycle.

Key responsibilities:

A. Regulatory Affairs
1. Handle CDSCO registrations, licenses, renewals, and compliance for Class A, B, C, and D medical devices.
2. Prepare, review, and submit regulatory documentation for India, EU (MDR), and US FDA markets.
3. Act as the primary liaison with regulatory authorities, notified bodies, and auditors.
4. Monitor regulatory updates and assess impact on existing and upcoming products.
5. Support regulatory strategy, product classification, and market entry planning.

B. Quality Management System (QMS)
1. Establish, implement, and maintain a QMS compliant with ISO 13485.
2. Ensure ISO 27001 compliance for information security related to software and connected medical devices.
3. Plan and conduct internal audits, supplier audits, and management reviews.
4. Manage CAPA, deviations, non-conformances, and change management.
5. Support certification, surveillance, and re-certification audits.

C. Standards & Technical Compliance
1. Coordinate product testing, validation, and certification with NABL/ILAC-accredited laboratories.
2. Maintain Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR).
3. Ensure compliance with applicable IEC standards, including but not limited to:
IEC 60601 (Medical Electrical Equipment Safety)
IEC 62304 (Medical Device Software Lifecycle)
IEC 62366 (Usability Engineering)
IEC 60601-1-2 (EMC)

D. EU MDR & FDA Compliance
1. Prepare and maintain EU MDR Technical Documentation, including Clinical Evaluation Reports (CER), PMS, and PMCF plans.
2. Ensure compliance with UDI, labeling, IFU, vigilance, and post-market surveillance requirements.
3. Support the FDA Quality System Regulation (21 CFR 820) and FDA inspections or audits.

E. Cross-Functional Collaboration
1. Work closely with R&D, Product, Manufacturing, Software, and Clinical teams.
2. Provide regulatory guidance during design controls and product development stages.
3. Conduct internal training sessions on regulatory and quality requirements.

Number of Openings

1 openings

Skills

Report Writing, Auditing, Technical Writing, Quality Assurance/Quality Control (QA/QC), Statutory compliances, Document Management, Document Review, Qualitative Research