Technical Officer - Medical Devices, Bangladesh
Job Description
Title: Technical Officer - Medical Devices, Bangladesh
Company Name: U.S. Pharmacopeial Convention
Vacancy: Not specific
Job Location: Dhaka
Employment Status: Full-time
Educational Requirements:
∎ Master/Bachelor's degree in Biology, Biochemistry, Medical technology, Biomedical Engineering, public health regulations or related Life Science degree.
Experience Requirements:
∎ At least 6 year(s)
Job Context:
∎ The Promoting the Quality of Medicines Plus (PQM+) program, funded by USAID and implemented by USP, improves access to quality-assured priority medicines and addresses the proliferation of poor-quality medical products in low- and middle-income countries. PQM+ will strengthen medical product quality assurance systems through cross-sectoral and systems-strengthening approaches and the application of international quality assurance standards across the pharmaceutical system. By sharing scientific expertise and providing technical support and leadership, PQM+ helps create resilient and robust local health systems that address diseases like HIV/AIDS, tuberculosis, malaria, and neglected tropical diseases, as well as improve maternal, newborn, and child health.
∎ PQM+ is seeking a Technical Officer-Medical Device. This role is responsible and accountable for providing technical assistance and oversight to regulators and manufacturers to achieve the objectives of growing the supply of quality-assured critical medical devices (MDs) and in-vitro diagnostic devices (IVDs) in the country. The Technical Officer will partner with internal USP departments as well as local governments and industry of MDs and/or IVDs to be a trusted authority providing guidance in the areas of MD and IVD regulation and manufacturing.
∎ Supervisory Responsibilities: None
∎ Position Type: Full-time/Regular
∎ Job Category: Global Health and Manufacturing Services
Job Responsibilities:
∎ Work with USP leaders to provide the basics of established regulatory frameworks and demonstrate significant quality assurance requirements and concepts surrounding development and market authorization of medical devices.
∎ Provide technical guidance and input in the adoption and/or development of guidelines, standard operating procedures (SOPs) following the international standards i.e., ISO, WHO, EU to implement effective regulation by NRA.
∎ Provide trainings to improve staff proficiency to establish effective medical device regulations in the field of quality testing, registration, marketing authorization, post-marketing surveillance, and vigilance within the National Regulatory Agencies.
∎ Partner to strengthen the post-market surveillance and vigilance program within the NRA intended to handle device performance and ensure device quality and safety.
∎ Provide support to maintain and improve the QA/QC and QMS system at the medical device laboratory of National Control Laboratory (NCL).
∎ Work closely with the PQM+ team to ensure that the program's technical approach for medical devices efficiency and safety monitoring is coordinated within the initiative's offerings.
∎ Develop the implementation of work plan activities related to medical devices safety monitoring as well as other regulatory systems strengthening interventions of the PQM+ Program.
∎ Ensures country program staff participate in and supply to PQM+ knowledge-sharing activities.
∎ Supervisory Responsibilities: None
Additional Requirements:
∎ 6-years of experience in similar fields.
∎ Subject matter knowledge in manufacturing processes, quality testing, stability studies, analytical method development, and regulatory filings.
∎ Experience in QA/QC, pharmacovigilance, safety surveillance, clinical pharmacy, medical product manufacturing and pharmaceutical regulation.
∎ Knowledge of regulatory requirements related to the development and manufacture of medical device in all phases of product development
∎ Experience in collection, management, analysis, and interpretation of quantitative data in development projects implemented by national/international government organizations, including experience drafting performance reports for donor funded projects.
∎ Detailed understanding of medical products, Manufacturing and Controls and Good Manufacturing Practices (GMP) for MDs and IVDs, packaging and other relevant areas
∎ Experience with regulatory authority registration processes
∎ Excellent English-language communication skills (written and oral)
∎ Comprehensive attention to detail and dedication to data integrity
∎ Excellent knowledge of performance monitoring, especially of health system strengthening interventions
∎ Experience in quantitative and qualitative data collection including survey design, implementation, and analysis
∎ Strong analytical skills of medical instruments.
∎ Ability to work independently, and with the team to coordinate activities between different agencies that PQM+ works with.
∎ Understanding of project cycle management.
∎ Creative knowledge of the application and monitoring of methodology: Good understanding of capacity assessment methodologies; excellent ability to identify significant capacity building opportunities.
∎ Ability to balance multiple priorities in a fast-paced environment
∎ Understanding about health programs HIV/ AIDS, malaria, TB, NTDs, AMR, MNCH is added advantage
Compensation & Other Benefits:
∎ USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing is protected.
Job Source: Bdjobs.com Online Job Posting.
Application Deadline: 24 Dec 2022
Company Information:
∎ 11 Dec 2022
∎ U.S. Pharmacopeial Convention
∎ Business : The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization founded in 1820. It 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.
Category: Medical/Pharma
Deadline Expired on 24th Dec 2022
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