Medical Devices Regulatory Officer (X1)

Reports To: Manager, Medical Devices

Job Grade: Band 4

Closing Date for Submission: 29/05/2025.
Only short-listed candidates will be contacted.

Job Summary

To provide support to the Manager, to deliver evaluation, registration, vigilance, and inspectorate services for medical devices at BOMRA.

Key Responsibilities:

• To regulate, control, and monitor all matters related to medical devices.
• To conduct evaluation for medical devices including 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 / reagents).
• To monitor post-market surveillance and vigilance system of medical devices used in the country.
• To undertake timely, regular inspection and licensing of premises dealing in the manufacture,
• importation, storage, distribution, dispensing of medical devices (including those for human and veterinary use) in both the private and public sectors.
• To conduct assessments of medical device manufacturers for compliance with Quality Audits prior to recommending products for market authorization.
• To coordinate and participate in the verification of pro-forma invoices for importation of medical devices and equipment; and ensure compliance with registration and other requirements.
• To work closely with the BOMRA Enforcement Unit, key stakeholders, and other security organs to investigate suspected cases of illegal/ criminal activities related to medical device importation, handling, distribution, and use.
• To sensitize the various stakeholders on the need to comply with the provisions of the Medicines and Related Substances Act (2013).
• Mentoring and training of new employees.
• To perform any other duties assigned by the supervisor from time to time.

Knowledge and experience

Candidates must hold a Bachelor’s degree in Biomedical Engineering or a related field. A Master’s degree or a postgraduate certificate in Medical Devices Regulatory Affairs will be an added advantage. A minimum of two years of professional experience in the regulation of medical devices, including in vitro diagnostics (IVDs), is required. The ideal candidate should have relevant training and/ or experience in Quality Management System (QMS) standards such as ISO 9001, ISO 17020, and ISO 13485, including demonstrated audit skills.

Training in healthcare technology and experience with medical devices, including in vitro diagnostics (IVDs), dossier submissions, and/or the assessment of high-risk medical devices, such as software as a medical device (SaMD) and artificial intelligence in medical devices, are essential. Additionally, familiarity with Medicines Regulatory Information Management Systems (MRIMS) and other ICT applications is required. Advanced knowledge of medical devices, regulatory processes, applicable standards, and good regulatory practices is crucial. Training in medical device regulatory affairs and prior experience in the
regulatory industry will be considered an added advantage.

Competencies

The candidate must demonstrate the ability to write clear and comprehensive technical reports; possess strong organizational, planning, and time management skills; exhibit creative and analytical thinking; demonstrate excellent oral and written communication skills; and display strong interpersonal skills with the ability to work collaboratively with colleagues to achieve organizational goals.

If you believe that you have the above capabilities, meet the minimum requirements, and would like to
grow with BoMRA, kindly send your application, latest CV, certified copies of certificates, and two (2) current referees’ details to: recruitment@bomra.co.bw