JOSEPH DONKOR ISSACHAR
Accra
Summary
Dynamic Regulatory Officer with proven expertise in medical device registration and quality assurance, developed through experience at the Food and Drugs Authority. Demonstrated success in engaging stakeholders and conducting rigorous compliance assessments to ensure regulatory adherence. Highly skilled in data management and report writing, facilitating effective communication and strategic planning for project success. Committed to advancing regulatory affairs through innovative compliance strategies, risk management, and comprehensive documentation.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Regulatory Officer
Food and Drugs Authority
02.2016 - Current
- Evaluate dossiers & register Class I–IV medical devices
- Conduct product quality monitoring & compliance assessments
- Process & submit samples to the Quality Control Laboratory
- Investigate consumer complaints & assist in enforcement activities
- Prepare & submit departmental reports
- Stakeholder engagement of the current regulatory requirements for the r]market authorization of medical devices
- Investigated allegations of non-compliance with applicable laws and regulations.
- Conducted research on legal, industry, and government regulations related to the organization's operations.
Field Engineer
Hanisa Medical Support Services
02.2015 - 01.2016
- Installed & maintained Anaesthesia machines, Ultrasounds, patient monitors, & autoclaves
- Conducted preventive maintenance of medical equipment
- Trained healthcare personnel on medical device usage & maintenance
National Service
37 Military Hospital – Electromed Department
09.2013 - 08.2014
- Installed & calibrated medical devices (Defibrillators, Dialysis Machines, BP Monitors, Ventilators, etc.)
- Conducted repairs & preventive maintenance
- Trained hospital staff on proper equipment use
Education
BSc. - Biomedical Engineering
Kwame Nkrumah University of Science and Technology
05.2013
W.A.S.S.C.E Certificate -
Presbyterian Boys Senior High School
Legon06.2008
B.E.C.E Certificate -
Morning Star Junior High School
05.2005
Skills
- Knowledge of medical diagnostics
- Quality assurance
- Healthcare research
- Data management
- Medical device registration
- Technical documentation
- Regulatory compliance assessments
- Policy adherence
- Project management
- Equipment maintenance
- Risk management
- Report writing
- Excellent communication
- Stakeholder engagement
- Strategic planning
- Organization
- Proficiency in Microsoft Office Suite
- MATLAB
- C – Primer Plus
- LABview
- Arduino Programming
- Data analysis
Affiliations
- Member, Ghana Society of Biomedical Engineers
- Member, Ghana Institute of Engineers
Certification
Project Management Professional (PMP) Certification, Ongoing
Training
- 2024, Assessment of Technical Files for Blood Screening in Vitro Diagnostic Medical Devices (IVDs)
- 2023, Medical Device Regulatory Convergence Project (MDRC), Africa Medical Devices Forum (AMDF)
- 2022, Data Protection Impact Assessment Training (AUDA-NEPAD)
- 2021, Assessment of Technical Files for Blood Screening IVDs
- 2021, Implementation Research
- 2020, Digital Health, Biomedical Visualization, Health Informatics, Healthcare Market Place
- 2019, Inspection of Blood Establishments
- 2018, Pharmaceutical Crime, Investigations & Intelligence
References
- Major Jude Boahen, Biomedical Engineer, OIC 37 Military Hospital Biomed Department, 0242616864
- Dr. Lawrence K. Appiah, Orthopaedic Surgeon, Nuffield Clinic, 0208112100
- Mr. Ibrahim Larchie, Lecturer, Biomedical Engineering Dept., KNUST, +233202336594, zlarchie@gmail.com
- Mr. Isaac Borteye, Technical Services Manager, Hanisa Medical Support Services, +233244335694, iborteye@hanisagroup.co
Languages
English
First Language
Timeline
Regulatory Officer
Food and Drugs Authority
02.2016 - Current
Field Engineer
Hanisa Medical Support Services
02.2015 - 01.2016
National Service
37 Military Hospital – Electromed Department
09.2013 - 08.2014
BSc. - Biomedical Engineering
Kwame Nkrumah University of Science and Technology
W.A.S.S.C.E Certificate -
Presbyterian Boys Senior High School
B.E.C.E Certificate -
Morning Star Junior High School
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