
Sonu J M
Biomedical Trainee

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About me
Regulatory Affairs | Medical Device| IVD | Compliance | EU MDR | 510(K) | ISO 13485 | CER | PMS- Complaint Handling| ASEAN | Risk Management | Tech- Dossier Submission
Education

Good Shepherd Matric School
2004 - 201888%
Jerusalem College of Engineering - India
2018 - 2022Bachelor of Engineering - BE Biomedical/Medical Engineering First Class
Experience

Dr.Somervell Memorial C.S.I Medical College & Hospital
Jan 2020 - Jan 2020Biomedical Trainee
HCL Technologies
Sept 2022 - nowProduct Regulatory AnalystMedical Device, IVD, ISO 13485, EU MDR, 510(k), GSPR, PMS, CER, Global Regulatory Submission, ASEAN, MAUDE Database Analysis
Licenses & Certifications

Cambridge English Entry Level Certificate in ESOL International(Entry 2)(Business)*
Cambridge Assessment EnglishApr 2019
Coursera Certificate on Drug Discovery
UC San DiegoAug 2021
Structuring Machine Learning Projects
DeepLearning.AIMay 2020
Mini course on MDR 2017/745
Easy Medical DeviceAug 2022
Hospital Internship
Deepam HospitalsNov 2020
Understanding how medical device are regulated in Canada
Canadian Institutes of Health Research | Instituts de recherche en santé du CanadaNov 2022
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