Vacancy: Medical Devices Consultant

Company Profile

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed, and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.

USP is an independent organization with nearly 200 years of experience developing quality standards for medicines. Through its global public health programs, USP strengthens medicines quality assurance systems, increases the supply of quality-assured medicines, and develops capacity to detect and remove poor-quality medicines from the market. By sharing scientific expertise and providing technical support and leadership, USP helps local regulators improve and sustain local health systems and enables manufacturers to supply quality-assured essential medicines for years to come. Through these efforts, USP is able to help detect and identify poor quality health products in disease areas such as HIV/AIDS, tuberculosis, malaria and neglected tropical diseases, as well as helping safeguard the maternal, newborn, and child health sectors.

Job Description

The regulation of medical devices is an essential part of regulation and hence forms a part of Regulatory systems strengthening. USP-Ghana requires the services of an expert to conduct training in the assessment of dossiers presented for medical devices.

Responsibilities:

• Develop and update materials for the delivery of trainings in medical devices dossiers evaluation in accordance with international guidelines/standard (WHO, BSI etc.) and best practices.


• Develop materials to cover:


• Basic levels of control for medical devices.


• Advanced regulatory systems for medical devices


• Assessment of common submission dossier template


• Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices and


• Common Medical Devices being employed during the COVID-19.


• Deliver trainings in medical devices dossiers compilation and evaluation.


• Provide hands-on coaching for dossier assessors

Required Skills or Experience

Requisites:

• Should have background in life sciences with a regulatory knowledge and experience for at least 5 years in medical devices regulation.


• Ability to teach with relevant examples and expertise.