swetha varadarajan

Experienced Biomedical Engineer specializing in Design Quality Standards in Medical Devices/Biotech Industry

Experienced Biomedical Engineer specializing in Design Quality Standards and Regulations 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 62366, with ability to adapt and learn quickly in challenging environments

- Proven track record of leading cross-functional teams to ensure successful completion of design projects throughout Product realization - from Concept to Market launch

- Focus Areas: Medical Devices, IVD Instruments and Reagents, and Software
- Revamped internal processes for Risk Assessment and Mitigation, CAPA Management and authored training courses for the organization
- Led a team of 11 people across geographies to deliver Essential Regulatory documentation for Type Testing and registration to the China FDA (NMPA)
- Promoted collaborations across multiple functions to resolve CAPA and Health Hazard Evaluation (HHE)

- Pioneered seamless integration of Quality processes of acquired companies into ours

Masters in Biomedical Engineering from Arizona State University