Hari Adithya
Biomedical engineer, ISO 13485:2016 CQI and IRCA certified Lead Auditor, EU MDR 2017, 510(k), PMA, ISO 14971, ISO 15223, IEC 62304.
- Role
- Regulatory Affairs & Quality Assurance Specialist at Capgemini
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Hari Adithya
A competent Biomedical Engineer with 4+ years of experience in Regulatory Affairs and Quality Engineering in the medical device industry. Expertise in key regulatory standards and frameworks, including EU MDR 2017/745, US FDA 510(k) submissions, ISO 13485:2016 Medical Device QMS, ISO 14971:2019 Risk Management, ISO 15223- 1 Labeling, ISO 62366-1 Usability Engineering, IEC 62304 Software Lifecycle, and ISO 20417 Medical Device Labeling. Proficient in regulatory compliance, quality management systems (QMS), risk management processes, and technical documentation. Demonstrated ability to ensure compliance with international standards, drive product quality, and maintain regulatory approvals across all stages of the medical device lifecycle. Seeking a challenging opportunity in a dynamic organization to leverage my skills in regulatory affairs and quality engineering for the growth of the company.
Experience
Regulatory Affairs & Quality Assurance Specialist
Jun 2021 — Present
EU MDR 2017 submissions 510k submissions ISO 13485:2015 MD QMSISO 14971: 2019 RMSIEC 62304 Medical device Software Lifecycle
Education
RVS school of Engineering college
Bachelor of Engineering - BE, Biomedical/Medical Engineering
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