Medical Devices Regulatory Officer – BoMRA (Botswana) – Apply by 29 May 2025
Job Opportunity: Medical Devices Regulatory Officer – BoMRA (Botswana) – Apply by 29 May 2025
Location: Gaborone, Botswana
Position: Medical Devices Regulatory Officer
Contract Type: Fixed-Term
Closing Date: 29 May 2025
Organization: Botswana Medicines Regulatory Authority (BoMRA)
Overview:
The Botswana Medicines Regulatory Authority (BoMRA) is seeking a qualified and experienced Medical Devices Regulatory Officer to support the regulation of medical devices and in vitro diagnostics (IVDs). Reporting to the Manager of Medical Devices, the successful candidate will be responsible for ensuring the safety, quality, and efficacy of medical devices available in the Botswana market through comprehensive evaluation, inspection, and post-market surveillance activities.
Position Purpose:
To deliver regulatory oversight for medical devices and IVDs by conducting conformity assessments, monitoring compliance, coordinating inspections, and participating in both national and international regulatory initiatives. The officer will play a vital role in safeguarding public health through effective regulation of medical technologies.
Key Responsibilities:
-Conduct technical evaluations for the registration of medical devices and IVDs to ensure compliance with safety, quality, and efficacy standards.
-Develop guidelines and standards for conformity assessments and regulatory compliance procedures.
-Monitor and implement post-market surveillance systems, including vigilance reporting for medical devices.
-Inspect and license premises involved in the importation, distribution, and use of medical devices.
-Assess manufacturing facilities for compliance with quality assurance standards and recommend authorization or certification.
-Verify imported medical devices for compliance with national standards and regulatory requirements.
-Support enforcement units in verifying and monitoring registered devices.
-Represent BoMRA in regional and international forums such as SADC, WHO, and IMDRF.
-Perform any other duties as assigned by the supervisor.
Minimum Requirements:
-Bachelor’s degree in Biomedical Engineering, Medical Laboratory Science, Medical Physics, or related field (Master’s degree is an added advantage).
-Minimum of 5 years’ regulatory experience, with at least 3 years in medical device or IVD regulation, evaluation, or assessment.
-Proficiency in post-market surveillance, inspections, and knowledge of relevant standards (ISO 13485, ISO 9001, ISO 17021).
-Understanding of international regulatory frameworks, including WHO and IMDRF guidelines.
Preferred Skills and Competencies:
-Strong analytical, communication, and negotiation skills.
-Project management ability and experience working in multidisciplinary teams.
-Capable of handling multiple responsibilities in a deadline-driven environment.
-High ethical standards and attention to regulatory detail.
-Proficiency with Microsoft Office Suite, data analysis tools, and regulatory software platforms.
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