QARA Lead/Senior

Foundation for Science, Innovation and Development, IISc Bangalore; Bengaluru; Sur place; INR 1 500 000 - 2 300 000; Plein temps

Résumé du poste

Foundation for Science, Innovation and Development, IISc Bangalore is seeking a QARA Lead to drive quality management and regulatory compliance for medical devices. You will establish ISO 13485:2016 aligned QMS and oversee design controls, risk management, and documentation.

You will manage regulatory submissions to CDSCO, US FDA, and EU MDR, lead internal/external audits, CAPA, and ensure supplier quality and post-market surveillance while collaborating with engineering and product teams to

Qualifications

• Hands-on ISO 13485 implementation and regulatory submissions.
• Knowledge of key standards and Indian Medical Devices Rules, 2017.

Responsabilités

• Establish and run an end-to-end QMS aligned with ISO 13485:2016.
• Lead design controls, risk management, and technical documentation.
• Drive regulatory submissions and approvals for CDSCO, US FDA 510(k), and EU MDR.
• Manage internal/external audits, CAPA, and quality metrics.
• Oversee supplier quality, manufacturing validation, and process controls.
• Support packaging, sterilisation validation, and post-market surveillance.
• Implement document control and training systems.
• Collaborate with cross-functional engineering and product teams.

Connaissances

Quality Assurance

Regulatory Affairs

ISO 13485

Risk Management

Design Controls

Regulatory Submissions

Audits

CAPA

Documentation

Formation

Bachelor's degree in Engineering, Biomedical Sciences, Life Sciences, or related field

Description du poste

We're Hiring | QARA Lead – Medical Devices

We are looking for an experienced Quality Assurance & Regulatory Affairs (QARA) Lead to drive quality management systems, regulatory compliance, and product certification for innovative medical devices.

• Establish and implement an end-to-end QMS aligned with ISO 13485:2016.


• Lead design controls, risk management, and technical documentation.


• Drive regulatory submissions and approvals for CDSCO, US FDA (510(k)), and EU MDR.


• Manage internal/external audits, CAPA, and quality performance metrics.


• Oversee supplier quality, manufacturing validation, and process controls.


• Support packaging, sterilisation validation, and post-market surveillance.


• Implement effective document control and training systems.


• Collaborate with cross‑functional engineering and product development teams.

Qualifications & Skills:

• Bachelor's degree in Engineering, Biomedical Sciences, Life Sciences, or a related field.


• 5–7 years of experience in Quality Assurance and Regulatory Affairs for medical devices.


• Hands‑on experience implementing ISO 13485 and preparing regulatory submissions.


• Strong understanding of ISO 14971, IEC 62304, IEC 60601, IEC 62366-1, ISO 10993, ISO 11607, and Indian Medical Devices Rules, 2017.


• Familiarity with Class II or higher-risk medical devices and international regulatory pathways.


• ISO 13485 Internal Auditor certification preferred.

What We're Looking For

A proactive, detail-oriented professional who can take ownership of quality and regulatory activities, work closely with multidisciplinary teams, and help bring safe, compliant medical devices to market.