The U.S. Pharmacopeial Convention (USP) Technical Advisor - Regulatory Systems Strengthening - Medical Devices in Rockville, Maryland
The Technical Advisor, Regulatory Systems Strengthening (RSS) is an integral member of the PQM+ technical team focusing primarily on medical devices. As a member of the program’s Center of Excellence (COE), the Advisor will lead the program’s work in the area of medical devices regulation including invitro diagnostics, act as the external focal point and inform the program on latest trends and practices while also managing and tracking the development and deployment of technical content. The Advisor will also collaborate with other technical leads within Global Health Manufacturing Services to advance the program’s approach and identify opportunities for continuous quality improvement.
Roles and Responsibilities
Leads in the development, deployment and continuous improvement of strategies and approaches to advance the regulatory review and manufacture of medical devices
Provides technical assistance and support to regulatory agencies in low- and middle-income countries to strengthen medical devices and diagnostics regulation
Identifies and performs assessment of capabilities, strengths, and weaknesses of medical devices relevant to USAID and low and middle -income countries and subsequently providing written reviews and analysis.
Monitors, reports and disseminates new medical device innovations arising from the PQM+ technical team, the program’s partners to staff and external stakeholders.
Accountable for developing and tracking the in-house capacity development of staff and PQM+ CORE-FLEX partners.
Works closely with the Sr. Technical Advisor, RSS to ensure the program’s technical approach for medical devices is integrated within the program’s offerings
Leads the implementation of work plan activities related to medical devices and other regulatory systems strengthening interventions of the PQM+ Program.
Provides leadership in the facilitation of LMICs adaptation of international standards and guidelines from the Medical Device Regulators Forum (IMDRF) and World Health Organization (WHO) and their participation in regulatory harmonization and convergence initiatives.
Responsible for keeping abreast of trends and new innovations related to medical devices
Works closely with PQM+ Senior Workforce Development Advisor in the development and revision of PQM+ approaches and best practices related to the delivery of trainings around medical devices
Responsible for the preparation and review of technical content for assigned work plans
Supports the delivery of work plan activities for pharmaceuticals in PQM+ countries
B.S. in regulatory affairs, engineering, pharmaceutical sciences, chemistry, public health or related field
Five (5) years of experience working in the regulatory review of medical devices
Demonstrated experience in at least one of the following areas: HIV/ AIDS, malaria, TB, NTDs, AMR, MNCH
Strong written (especially technical writing) and oral communication skills
Willingness to travel at least 25% of the time.
Five (5) years’ experience in designing and implementing projects that contribute to stronger health systems and improve health outcomes in low- and middle-income countries.
Regulatory Affairs Professional Society (RAPS) certification
A MS or PhD in engineering, pharmaceutical sciences, chemistry, public health or related field
Direct experience and understanding of the WHO Global Benchmarking Tool
Demonstrated experience in supporting clients with quality management systems for ISO 13485 - medical device regulation, post-market surveillance and quality assurance
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Job Category Technical Programs
Job Type Full-Time