DEEPAK RADJOU
Hamilton,Ontario
Summary
Dynamic regulatory affairs professional with experience at Aarvam Medicals, adept in EU MDR and ISO standards. Proven track record in enhancing procedural efficiency and reducing device-related issues. Skilled in regulatory writing and project management, with a strong focus on compliance and risk management in the biotech industry.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Regulatory Affairs Intern
Crown Medical Research and Pharmaceutical Sciences College of Canada
Toronto, Canada
04.2024 - 06.2024
- I completed an internship project at Crown Medical Research and Pharmaceutical Sciences College of Canada, collaborating with Northeastern University XN
- Under Professor Peivand Pirouzi's guidance, I focused on preparing NDS in CTD format for Health Canada
- My responsibilities included interpreting regulations, compiling documents, and developing a Regulatory Strategy
- This experience enhanced my skills in regulatory affairs and medical documentation preparation, preparing me for a career in the biotech industry
Executive, Regulatory Affairs
Aarvam Medicals
Puducherry
09.2021 - 05.2022
- Led regulatory compliance for medical equipment and laser devices, ensuring adherence to national and international standards
- Provided hands-on training to doctors on the effective use of medical devices, improving procedural efficiency by 30%
- Conducted technical assessments and risk evaluations, reducing device-related issues by 25%
- Assisted in preparing regulatory documentation for market approvals, streamlining the submission process
Biomedical Engineer
East Coast Hospitals
Puducherry, India
07.2019 - 12.2020
- Spearheaded the implementation and maintenance of biomedical equipment and medical software, enhancing operational efficiency
- Developed and optimized medical procedures, leading to a 20% improvement in diagnostic accuracy and patient safety
- Prepared detailed technical reports on equipment performance, maintenance schedules, and compliance with healthcare regulations
- Collaborated with medical teams to train staff on the proper use of biomedical devices, reducing equipment-related errors by 15%
Education
Master of Science - Regulatory Affairs
Northeastern University
Toronto, Canada06-2024
Bachelor's - Biomedical Engineering
Rajiv Gandhi College of Engineering And Technology
Puducherry01.2018
Skills
- EU MDR
- US FDA
- Health Canada MDR
- 21 CFR 820
- ISO - 13485
- ISO - 14971
- ISO - 14155
- IEC - 62366
- IEC - 62304
- QMS
- MDSAP
- Regulatory Audits
- Risk Management
- Regulatory Writing
- Root Cause Analysis
- Project Management
- Data Analysis
- CAPA
- Document Management
- GMP
- FMEA
- Change control
- Adobe Creative Cloud
- MS Office Suite
- Google Suite
- EQMS
Certification
- DELF B2 (French)
- Lean Six Sigma
Projects
Managed end-to-end preparation of a Class IV medical device license application (MDL) for Health Canada. Created a 510(k) summary report for a medical device using the substantial equivalence concept. Developed regulatory strategies for SaMD device launches in Canada.
Volunteer Experience
RAPS Student Ambassador, 2023, Assisted in various projects and activities for attendees.
Personal Information
Title: Regulatory Affairs and Quality Assurance Specialist
Languages
French
Full Professional
English
Native/ Bilingual
Tamil
Native/ Bilingual
Accomplishments
- Mr. Puducherry, 2016 Bodybilding Gold medal
- Mr karaikal 2017 Bodybuilding silver medal
Timeline
Regulatory Affairs Intern
Crown Medical Research and Pharmaceutical Sciences College of Canada
04.2024 - 06.2024
Executive, Regulatory Affairs
Aarvam Medicals
09.2021 - 05.2022
Biomedical Engineer
East Coast Hospitals
07.2019 - 12.2020
Master of Science - Regulatory Affairs
Northeastern University
Bachelor's - Biomedical Engineering
Rajiv Gandhi College of Engineering And Technology
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