Job Expired

Vacancy

Job Summary

 The incumbent will report to the Manager, to deliver regulatory services for medical devices and in vitro diagnostics (IVDs) to ensure safe, quality, and inspected medical devices and IVDs are available at BoMRA.

Key Responsibilities

•To conduct evaluation of medical devices including in vitro diagnostics (IVDs) registration for safety, quality, and efficacy.

•To establish guidelines and standards for compliance with conformity assessment procedures of medical devices (evaluate new techniques/ registration).

•To monitor post-market surveillance and the vigilance system of medical devices used in the country.

•To undertake timely, regular inspection and licensing of premises dealing in the importation, storage, distribution, dispensing, and medical device (including those for human and veterinary uses) in both the private and public sectors.

•To conduct assessments of medical device manufacturers for compliance with quality standards for manufacturing authorization and certification.

•To coordinate and participate in the verification of medical devices imported into the country for compliance with the set standards.

•To verify and assess the conformity of medical devices registered with the BoMRA Enforcement Unit.

•To represent BoMRA at the SADC and other regional and international forums on regulatory matters for medical devices and IVDs.

•To carry out any other duties as may be assigned by the supervisor.

Knowledge and experience

•The candidate must possess a Bachelor’s degree in Biomedical Engineering, Medical Laboratory Science, Medical Physics, or a related field. A Master’s degree would be an added advantage.

•At least 5 years’ experience in the regulatory field, with a minimum of 3 years in medical devices or IVDs regulation, evaluation, or conformity assessment. Experience in post-market surveillance, inspections, and quality management systems (ISO 13485, ISO 9001, ISO 17021, and ISO 13485, including in demonstrated solid negotiation skills).

•Knowledge of the regulatory framework for medical devices and in vitro diagnostics (IVDs) in Botswana and internationally, including the World Health Organization (WHO) and International

Medical Device Regulators Forum (IMDRF) guidelines.

•Experience with medical device registration, conformity assessment, and international harmonization initiatives. Familiarity with Medicines Regulatory Authority collaboration, partnership with Medical Devices and/or International Agencies, and knowledge of the medical devices regulatory processes, applicable standards, and good regulatory practices is crucial. Training in medical device regulatory affairs and prior experience in regulatory harmonization initiatives would be considered an added advantage.

Competencies

•The candidate must demonstrate the ability to communicate effectively, work collaboratively in multidisciplinary teams, and possess strong analytical, problem-solving, and project management skills. Must be able to prioritize and manage multiple tasks, work under pressure, and maintain high ethical standards. Proficiency with MS Office, data analysis tools, and regulatory software is essential. The ability to work collaboratively with colleagues while achieving organizational goals is crucial.

More Information

JOB APPLICATION DETAILS
APPLICATION DETAILS
If you believe that you have the above capabilities, meet the minimum requirements, and would like to work with BoMRA, kindly submit your application, CV, and certified copies of certificates to [email protected] or hand deliver to BoMRA Head Office, Plot 112, Gaborone International Finance Park, Gaborone. Closing Date for Submission: 29/05/2025. Only short-listed candidates will be contacted

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