Sunny Babu
Digital Health | Product Management & Regulatory Affairs
Biomedical Engineer with 2+ years of experience in product management for medical software and experience as a Quality & Regulatory Affairs Manager and PRRC in digital health. I have led cross-functional product and release activities, supported risk management and regulatory documentation, and worked closely with clinical, engineering, and quality teams throughout the product life cycle. My strength lies in connecting product needs with quality and regulatory requirements and turning complex requirements into practical, scalable solutions.
Munich, Germany
0+
Years experience
0
Languages
0
Skills
Work Experience
Junior Quality & Regulatory Affairs Manager / PRRC
- Ensured regulatory readiness by maintaining and reviewing Technical Documentation and EU Declaration of Conformity for myoncare Careplan Manager & Mobile
- Strengthened QMS compliance through regulatory monitoring, gap assessments, document updates, and change-control activities
- Led ISO 13485 audit, CAPA, nonconformities, and post-market activities through regulatory evidence, corrective actions, and process improvements
- Driving initial FDA 510(k) preparation, including regulatory pathway assessment and submission planning
Junior Product Manager
- Ensured product and regulatory readiness by maintaining the Technical Documentation and Product Master File for a Class IIa medical device
- Integrated regulatory and quality requirements from MDR, ISO 13485, ISO 14971, and IEC 62304 into product development activities
- Coordinated release-ready product documentation, including IFUs, datasheets, design specifications, and related materials across QM/RA, R&D, service, and management
- Improved cross-functional product processes by working with QM/RA, R&D, UI/UX, service, and installation teams on usability, documentation, and product communication
- Translated user and business needs into product requirements, specifications, user stories, and structured product backlogs in collaboration with R&D and Product Management
Junior Product Manager
- Drove product discovery and development for ShuntWizard, an AI-driven vascular access monitoring app, including user needs, risk analysis, and regulatory documentation within a publicly funded research project
- Co-invented and contributed to the EU patent submission for the ShuntWizard digital health solution (Phase I Application)
- Managed interim product development for Mizu, a Class I medical device, including roadmap planning, sprint planning, retrospectives, release management, and QA coordination
- Bridged clinical, research, and technical teams to translate research objectives into product requirements and proof-of-concept solutions
- Improved product usability and performance by using user feedback, product analytics, and operational KPIs to identify and prioritize product improvements
Project Management Intern
- Supported global nephrology partnerships across EMEA through strategic reporting, stakeholder analysis, and actionable insights.
- Supported home dialysis initiatives and coordinated advisory boards and scientific events with internal and external stakeholders.
- Developed and delivered CKD medical education content for healthcare professionals across 159 countries through the Nephrology Campus platform.
- Completed a Master’s thesis on AVF blood-flow surveillance using machine learning, combining clinical application with data-driven technology.
Skills
Medical Device Regulatory Affairs – EU MDR 2017/745Quality Management Systems – ISO 13485Technical DocumentationRelease ManagementMedical Software Lifecycle – IEC 62304
Education
M.Sc. Digital Health, Digital Health
Technische Hochschule Deggendorf – European Campus Rottal-Inn
B.E. Biomedical Engineering, Biomedical Engineering
Anna University – PSNA College of Engineering & Technology
Certifications
Internal Auditing For Quality Management System for Medical Devices based on ISO 13485:2016
TÜV SÜD South Asia
Medical Device Regulation 2017/745 EU regulatory affairs
Udemy
ISO 13485:2016 for Medical Devices QMS (Updated 2025)
Udemy
Languages
German
Intermediate
English
Native
References available upon request.