Technical Officer, Quality and Regulation of Medical Devices

OBJECTIVE OF THE OFFICE/DEPARTMENT

This requisition is for employment at the Pan American Health Organization (PAHO)/Regional Office of the World Health Organization (WHO)

The Department of Innovation, Access to Medicines & Health Technologies (IMT) is responsible for promoting, coordinating, and implementing the Organization’s technical cooperation in access to and rational use of quality medicines and other health technologies. IMT works across all categories of medicines and health technologies, including medicines, vaccines, diagnostics, medical equipment, blood products and organs for transplantation. IMT supports countries in addressing barriers to access, addressing challenges across the medical product full life cycle, strengthening regulatory capacity and supporting evidence-based decision making and rational use through health technology assessment. IMT consolidates action in the development of pharmaceutical and other health technology related services and leads efforts in innovation through the regional platform to advance the manufacturing of vaccines and other health technologies, increasing regional capacity in the research and development of priority health products and supporting the generation of ecosystems to enable development, production and access to medicines and other health technologies. IMT is comprised of the following units and Special Program: Access to Medicines and Health Technologies (IMT/AH), Quality and Regulation of Medicines and Health Technologies (IMT/QR) and Special Program, Innovation and the Regional Production Platform (IMT/RP).

DESCRIPTION OF DUTIES

Under the general supervision of the Director, Innovation, Access to Medicines and Health Technologies (IMT), and the direct supervision of the Unit Chief, Quality and Regulation of Medicines and Health Technologies (IMT/QR), the incumbent is responsible for, but not necessarily limited to, the following assigned duties:

1.Provide technical support to the Quality and Regulation of Medicines and Health Technologies Unit for the systematization ofprocesses and information for dissemination, to advocate / support regulatory decision-making processes;

2.Participate in the implementation and development of the technical activities of the Quality and Regulation of Medicines andHealth Technologies Unit as defined in the Biennial Work Plan (BWP);

3.Develop, update and apply eligibility criteria and technical requirements for the evaluation of manufacturers, suppliers and products, according to international standards to support the procurement of medical devices, including IVDs, procured by PAHO Revolving Funds and/or other PAHO mechanisms;

4.Generate Standard Operating Procedures (SOPs) for the routine processes and promote cross training between members of the group;

5.Develop technical reports to support the quality assurance process of medical devices, including IVDs, procured by the PAHO Revolving Funds and/or other mechanisms on behalf of Member States;

6.Provide technical support to Member States and other stakeholders on matters related to quality and regulation of medical devices, including quality control laboratories and prequalification processes;

7.Promote and coordinate the participation of subject matter experts (SME)from Regional, National Regulatory Authorities and relevant actors in harmonization and convergence initiatives related to medical devices, including IVD;

8.Coordinate and participate in technical activities related to the strengthening of national regulatory capacities, including post market surveillance of medical devices;

9.Support the mobilization of financial resources for national and regional projects;

10.Participate in meetings with internal and/or external stakeholders, including national and regional meetings with PAHO Member States, to provide technical recommendations related to health technology management (HTM);

11.Liaise with technical counterparts in WHO and WHO’s Regional Offices to share experiences and harmonize criteria for the evaluation and assessment of medical devices;

12.Perform other related duties, as assigned.

REQUIRED QUALIFICATIONS

Education:

Essential: A bachelor’s degree in pharmacy, biomedical engineering or a health science related to the functions of the position, from a recognized university.

Desirable: A master’s degree in pharmacy, biomedical or related field, from a recognized university would be an asset.

In the event that your candidature is retained for an interview, you will be required to provide, in advance, a scanned copy of the degree(s)/diploma(s)/certificate(s) required for this position.WHO, only considers higher educational qualifications obtained from an institution accredited/recognized in the World Higher Education Database (WHED), a list updated by the International Association of Universities (IAU) / United Nations Educational, Scientific and Cultural Organization (UNESCO). The list can be accessed through the link: http://www.whed.net/. PAHO will also use the databases of the Council for Higher Education Accreditation http://www.chea.org and College Navigator, found on the website of the National Centre for Educational Statistics, https://nces.ed.gov/collegenavigator to support the validation process.

Experience:

Essential: Seven years of combined national and international experience in programs or activities related to health technologies, medical devices management, regulatory systems, quality management systems or quality assurance of medical devices.

Desirable: Two years of experience in UN procurement processes and/or work experience on ISO standards (13485 and/or 17025) would be an asset.

SKILLS:

PAHO Competencies:

·Overall attitude at work: Maintains integrity and takes a clear ethical approach and stance; demonstrates commitment to the Organization’s mandate and promotes the values of the Organization in daily work and behavior; is accountable for work carried out in line with own role and responsibilities; is respectful towards, and trusted by, colleagues and counterparts.

·Teamwork: Collaborate and cooperate with others/Deal effectively with conflict - Creates team spirit; promotes collaboration and open communication in the team; proactively supports others; welcomes team responsibilities and drives team results; promotes knowledge sharing in the team. Proactively identifies conflicts and facilitates their resolution in a respectful manner; tactfully resolves conflicts between or with others and takes action to reduce any possible tension; effectively builds a rapport with individuals and teams, establishing good personal and professional relationships, as well as minimizing risk of potential conflict.

·Respecting and promoting individual and cultural differences: Relate well to diversity in others and capitalize on such diversity - Treats all people with dignity and respect. Relates well to people with different cultures, gender, orientations, backgrounds and/or positions; examines own behavior to avoid stereotypical responses; considers issues from the perspective of others and values their diversity.

·Communication: Express oneself clearly when speaking/Listen/Write effectively/Share knowledge - Foresees communication needs of audience and targets message accordingly. Facilitates open communication; encourages others to share their views openly and takes time to understand and consider their views. Writes down ideas in a clear, structured, logical and credible way; drafts and supports the development of guidelines, policies and procedures. Shares relevant information openly and ensures that the shared information is understood; considers knowledge sharing as a constructive working method and demonstrates awareness of the Organization.

·Producing Results: Work efficiently and independently/Deliver quality results/Take responsibility - Prioritizes work, monitors own progress against objectives and adapts plans as required; communicates adjustments as necessary. Acts proactively and stimulates action as needed; handles problems effectively and constructively. Produces high-quality results and workable solutions that meet clients’ needs. Works independently to produce new results and sets own timelines effectively and efficiently. Shows awareness of own role and clarifies roles of team members in relation to project’s expected results. Makes proposals for improving processes as required and takes responsibility for own work and/or actions, as necessary. Demonstrates positive attitude in working on new projects and initiatives. Demonstrates accountability for own success, as well as for errors; learns from experience.

·Moving forward in a changing environment: Propose change/Adapt to change - Actively supports Organizational change initiatives and demonstrates personal commitment to them, including when faced with new demands; proposes workable solutions to challenging situations. Engages in positive responses to a changing environment and promotes workable solutions to achieve own and team’s results. Welcomes, and actively seeks to apply, new ideas, approaches and working methods and technologies in order to improve own and/or team’s work processes and results; demonstrates commitment to Organizational change initiatives.

Technical Expertise:

·Ability to integrate and apply good procurement practices, quality assurance standards and/or compliance according to standard operational procedures and guidelines.

·Knowledge of international standards, WHO guidelines for safety, efficacy, and quality of medical devices, including IVDs.

·Capability to analyze technical information, synthesize inputs and support the development of criteria and provide quality decisions.

·Knowledge of regulatory systems and/or the essential regulatory functions of health technologies.

·Mature judgment, strong work ethics, ability to identify, assess, analyze, synthesize, and provide recommendation on key political and technical issues.

·Ability to manage multiple issues and tasks in a complex organizational environment to re-prioritize actions on short notice.

·Strong professional oral and writing skills, including the development of reports, oral presentations, and technical documents for consideration at the highest levels of the Organization.

Languages:

Very good knowledge of English and Spanish with working knowledge of the other language. Knowledge of French and/or Portuguese would be an asset.

IT Skills:

Demonstrated ability to effectively use current technology and software, in particular spreadsheets and presentations, as well as Enterprise Resource Planning (ERP) and management information systems. Additionally, familiarity with current IT software and platforms to implement Quality Management Systems and knowledge of other software programs such as SharePoint, Visio, Power BI, and Project would be an asset.

REMUNERATION

Annual Salary: (Net of taxes)

USD $64,121.00 post adjustment

Post Adjustment:70.2% of the above figure(s).This percentage is to be considered as indicative since variations may occur each month either upwards or downwards due to currency exchange rate fluctuations or inflation.

ADDITIONAL INFORMATION

This vacancy notice may be used to fill other similar positions at the same grade level.

Any appointment/extension of appointment is subject to PAHO Staff Regulations, Staff Rules and e-Manual.

For information on PAHO please visit: http://www.paho.org

PAHO/WHO is an ethical organization that maintains high standards of integrity and accountability. People joining PAHO are required to maintain these standards both in their professional work and personal activities.

PAHO/WHO also promotes a work environment that is free from harassment, sexual harassment, discrimination, and other types of abusive behavior. PAHO conducts background checks and will not hire anyone who has a substantiated history of abusive conduct.

PAHO/WHO personnel interact frequently with people in the communities we serve. To protect these people, PAHO has zero tolerance for sexual exploitation and abuse. People who commit serious wrongdoing will be terminated and may also face criminal prosecution.

PAHO/WHO is committed to workforce diversity. PAHO/WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.

PAHO/WHO offers an attractive compensation package including an annual net salary and post adjustment, which reflects the cost of living in a particular duty station and exchange rates (subject to mandatory deductions for pension contributions and health insurance).Other benefits include: 30 days annual leave, dependency benefits, pension plan and health insurance scheme. Benefits for internationally recruited staff may include home leave, travel and removal expenses on appointment and separation, education grant for dependent children, assignment grant and rental subsidy.

Candidates appointed to an international post with PAHO are subject to mobility and may be assigned to any activity or duty station of the Organization throughout the world.

All applicants are required to complete an on-line profile to be considered for this post.

Candidates will be contacted only if they are under serious consideration. A written test and/or interview will be held for this post.The post description is the official documentation for organization purposes.