SNKE - Proposal for the Application of the Regulatory Framework for Registration of Medical Devices in South Africa

Apply by 30 March 2018
Posted on 13 March 2018

Job Description

Human Dynamics is a leading European provider of consulting services for the public sector with more than 120 projects implemented in 30 countries worldwide. Currently, Human Dynamics and its 300 experts and consultants advise more than 40 ministries and public/government agencies worldwide. You are welcome on our website for more details: www.humandynamics.org

Project title: Technical assistance for the EU-South Africa Dialogue Facility

Brief description: A Human Dynamic’s led consortium has been selected to implement EuropeAids’ EUR 3.4 million, 42-month project, “Assistance for the EU-South Africa Dialogue Facility”. The proposed technical assistance’s focus is on the ‘EU-South Africa Dialogue Facility’ under the umbrella of the Strategic Partnership, a partnership that has existed between the EU and South Africa since 2007. Our team will support the Dialogue Facility to continue to deliver targeted technical assistance and support to South African government departments.

The overall objective of this assignment is aimed at providing decision makers in the South African Regulatory Authority with sufficient information and guideline options to make an informed judgement regarding the road map for the medical device registration process in South Africa.

The specific objectives of this assignment are:

  • To conduct a gap analysis of the medical device registration process in South Africa;
  • To facilitate a multi-stakeholder workshop to explore the themes of harmonisation, reliance and recognition;
  • To conduct an SA to EU study tour

Requested Services:

The assignment will have four phases:

  1. Phase One – Desk research and documented gap analysis report
  2. Phase Two – Multi stakeholder workshop in Pretoria, South Africa and documented workshop outcomes

III. Phase Three – SA to EU study tour (5 NDoH officials to be selected)

  1. Phase Four – Road map for medical device registration process in South Africa

The services to be provided will include:

  1. Documented gap analysis report to inform the development of a road map for the medical device registration process in South Africa;
  2. Participate in a multi-stakeholder workshop in Pretoria, South Africa; and
  3. Development of the road map for the medical device registration process in South Africa.

Commencement date of the assignment: April 2018

Duration of the assignment: 12 working days

Requirements:

  • At least Masters Degree: public health systems, health regulation, medicines, biology, pharmacy or equivalent
  • Minimum 10 years professional experience as a health regulator with an understanding of the harmonisation, reliance and recognition mechanisms
  • Preferably practical experience of managing the types of dossiers for medical device and medicine regulation; using and adapting assessment information from other experienced regulators
  • Demonstrated experience in institutional strengthening and organisational development of health regulatory authorities in the EU countries
  • Very good understanding of WHO, ICH, IMDRF and other international standards and best practices regarding regulation of medicines and medical devices
  • Demonstrated management experience and team leader skills
  • Strong report writing ability

About the Organization

Human Dynamics is a leading European provider of consulting services for the public sector with more than 120 projects implemented in 30 countries worldwide. Currently, Human Dynamics and its 300 experts and consultants advise more than 40 ministries and public/government agencies worldwide. You are welcome on our website for more details: www.humandynamics.org

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