? We're Hiring | QARA Lead – Medical Devices

? Location: Bengaluru, India (IISc Campus)

? Experience: 5–7 Years

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.

? Key Responsibilities:

- 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 secure, compliant medical devices to market. ? Interested candidates can share their resumes or reach out via LinkedIn DM.

- #Hiring #QARALead #MedicalDevices #QualityAssurance #RegulatoryAffairs #ISO13485 #CDSCO #USFDA #EUMDR #BengaluruJobs #MedTech #HealthcareInnovation

📌 QARA Lead/Senior (Bengaluru)
🏢 Foundation for Science, Innovation and Development, IISc Bangalore
📍 Bengaluru