Consultant- (Regulations)
Job Description
Title: Consultant- (Regulations)
Company Name: PATH
Vacancy: Not specific
Job Location: Dhaka
Employment Status: Contractual
Job Context:
∎ Start Date: 1st Nov 2022
∎ End Date: 31st May 2023
∎ Number of days: 40
∎ PATH, together with a consortium of partners (Hyperfine Research, King`s College London, and Flexport), is helping to facilitate and coordinate the delivery of POC MRI scanner systems to up to ten clinical trial study sites in seven low- and middle-income countries: Ethiopia, India, Bangladesh, Malawi, Pakistan, South Africa, Uganda, and Zambia. Supported by BMGF, the consortium of partners will support the principal investigators with delivery logistics, training, installation, and maintenance for the POC MRI scanner systems, as well as mentoring support for neuroimaging collection and interpretation. We seek to onboard a consultant with regulatory expertise to support the research partners in gaining necessary approvals and supporting the import of the device.
Job Responsibilities:
∎ Regulatory support on taking the academic or commercial route for performing study of the medical device in India taking into consideration the status of study sites.
∎ Prepare regulatory dossiers as per regulatory guidelines for various applications and other required documentation.
∎ Prepare regulatory application checklist for submission to regulatory authorities.
∎ Submit regulatory dossier, subsequent query resolution, and follow up.
∎ Preparation of endorsement applications and notification of post approval changes including major or minor.
∎ Liaison and follow up with regulatory authorities, frequent follow ups.
∎ Device Master File Preparation and Maintenance
∎ Regular intimation of the development of submitted application
∎ Registration of ethics committee at the sites (if required)
∎ Prepare pre-requisite documents for ethics committee approval (if required)
∎ Trial related update submissions, submissions to Ethics Committees and applicable regulatory bodies.
∎ Medical writing (Clinical/Operational Investigational plan, ICF, IB etc.) for device operational/clinical studies
∎ Regulatory/Quality GAP Analysis
∎ Providing support and working in collaboration with PI's at the sites
∎ Clinical/Operational Study Operations (Start-up, execution and close-out phases)
∎ Report writing (CSR, CER etc.)
∎ Risk Management (ISO 14971)
∎ Assistance with device labelling requirements
∎ Updating for the new guidelines and changes if any in the current procedure or regulations.
∎ Handling queries raised by respective authorities & assistance in providing appropriate response to the same
Job Source: Bdjobs.com Online Job Posting.
Application Deadline: 31 Oct 2022
Company Information:
∎ 13 Oct 2022
∎ PATH
Category: NGO/Development
