Medtronic

During my time at Medtronic’s Hyderabad facility, I served as a Senior Regulatory Specialist within the Diabetes business unit, supporting the Next-Generation Insulin Pump platform. My primary focus was on complaint handling and post-market regulatory compliance, working as part of a cross-functional global team committed to advancing device safety, usability, and performance for people living with diabetes.

This short-term yet high-impact assignment allowed me to contribute meaningfully to Medtronic’s mission of delivering life-transforming solutions through rigorous product oversight and continuous improvement in regulatory processes.

Key Responsibilities

My work was centered on the complaint handling process, specifically for Class II and Class III insulin pump systems. These systems were undergoing significant design upgrades in preparation for next-generation launches in regulated markets, including the U.S. and EU.

I collaborated with global complaint handling teams, quality engineers, and design assurance specialists to ensure that all field complaints were properly investigated, documented, and reported in accordance with applicable standards such as:

21 CFR Part 803 (MDR reporting)

EU MDR 2017/745 Post-Market Surveillance

ISO 13485:2016

Medtronic’s internal quality system procedures

My role included:

1. Assessing complaints for reportability based on risk to patient safety, device performance, and recurrence probability.

2. Working closely with investigators and product SMEs to ensure accurate root cause identification, CAPA linkage, and traceability of corrective actions.

3. Ensuring timely and compliant documentation within the eQMS system, including record reviews, audit readiness, and internal approvals.

4. Participating in regulatory reporting activities, including preparation of Health Hazard Evaluations (HHEs), 30-day and 5-day reports, and support for Vigilance Reports in the EU.

Project Involvement: Next-Generation Pump Complaint Trends

A core part of my role involved reviewing historical complaint data and trend reports for the next-gen insulin pump. Working with data analysts and regulatory leads, I helped highlight emerging themes related to:

• Sensor connectivity issues

• Adhesive and cartridge compatibility

• User interface concerns impacting dosage delivery

This analysis supported cross-functional inputs into Human Factors Engineering (HFE) reviews and contributed to risk file updates. The insights were shared with the global post-market team and factored into future design iterations.

Outcome and Impact

My contributions helped reinforce regulatory compliance readiness for the next-gen pump, ensured timely reporting to health authorities, and enabled a proactive risk posture by feeding complaint trends back into the product development cycle.

Though the assignment lasted four months, it significantly deepened my understanding of regulated post-market surveillance systems, field issue investigation processes, and the complexity of medical device safety in real-world use.

This experience reaffirmed my passion for bridging regulatory expertise with product performance and patient outcomes, especially in life-critical medical technologies.