Single-Use Medical Devices Quality Assurance & Regulatory Specialist At International Committee of the Red Cross

Reports to (role)

• Head Pharmacist (medical)

What we do

The International Committee of the Red Cross (ICRC) works worldwide to provide humanitarian assistance to people affected by conflict and armed violence. We take action in response to emergencies and at the same time promote respect for international humanitarian law. We are an independent and neutral organization, and our mandate stems essentially from the Geneva Conventions of 1949. We work closely with National Red Cross and Red Crescent Societies and with their International Federation in order to ensure a concerted, rational and rapid humanitarian response to the needs of the victims of armed conflict or any other situation of internal violence. We direct and coordinate the international activities conducted in these situations.

Purpose

The Quality Assurance & Regulatory Specialist develops, implements and maintains the quality management system (QMS) for Single Use Medical Devices & In-vitro Diagnostic Products. They ensure that all products are free from defects and compliant with relevant regulations, international and ICRC standards (GXPs and ISO) and are accountable for ensuring that the performance objectives of the QMS are met.

Main duties and responsibilities

• Responsible for the implementation, maintenance and documentation of the Quality Management System for single-use Medical Devices (MDs) and In Vitro Diagnostics (IVDs) and ensures alignment with the procurement strategy in regard to Regulatory and Quality requirements.
• Coordinates activities and at meeting quality standards and implements quality control processes and set up when requested.
• Identifies risks and root causes associated with items quality and safety and proposes/approves mitigation measures or solutions.
• Conducts and validates supplier audits and assessments against any applicable requirements: GDP and/or GMP, ISO 13485, ISO 9001.
• Approves products and suppliers of MDs & IVDs during international tenders (quality/regulatory/end-user perspective).
• Develops conformity assessment route, secures and approves domestic purchases made at country level.
• Provides global technical assistance on topics related to the quality of products. e.g: Sample Quality Evaluation, suppliers & products technical & quality documentation assessment (EC certificate, declaration of conformity, certificates of analysis etc.),
• testing report results and verifies their alignment with ICRC specifications and regulatory requirements.
• Monitors any changes to existing or introduction of new regulation (Regulatory Intelligence) and shares with relevant stakeholders.
• Manages and communicates, the introduction of new or alternative products or obsolescence of existing ones and updates item codes master data accordingly.
• Participates in recruitment and training of technical experts, manage them as a functional reporting line.
• May act as a “person for regulatory compliance” according to Article 15 of the European Medical Device Regulation.

People management responsibilities

• Manages a team of 2 as a functional/technical manager.

Scope & Impact

• Geographic remit: Global.

Relationships

• Internally, interacts with relevant units within the Assistance division and with stakeholders in the logistics division.
• Externally, interacts with suppliers, regulatory authorities, other NGOs, WHO.

Education and experience required

• Master’s or Pharmacist degree or specialist in Quality Management of single-use Medical Devices
• Typically, 10 years of overall professional experience.
• At least 4 years of relevant experience in a field related to, the medical device industry, and Quality Management.
• Strong knowledge of regulations, guidelines and standards such as ISO 13485, MDR (Regulations EU-2017/745), IVDR (EU- 2017/746), GMP, GDP; Knowledge of ISO 9001, 14001 and 45001.
• Experience in supplier assessments
• Experience in humanitarian contexts is an asset.
• Some travels may be required to visit suppliers and the delegations when needed.
• Fluent command of English and French, Spanish is an asset.
• Computer proficiency.

Additional information

• Location: Geneva
• Type of contract: Open-ended
• Starting date: ASAP
• Activity rate: 100%
• Application deadline: Sunday, 29 August 2021

The ICRC values diversity and is committed to creating an inclusive working environment. We welcome applications from all qualified candidates. Only candidates under serious consideration will be contacted.