Consultant, Regulatory

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PATH is a global nonprofit dedicated to achieving health equity. With more than 40 years of experience forging multisector partnerships and with expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world’s most pressing heath challenges.

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, 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.

Scope of work

• 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 application checklist for submission to regulatory authorities.

• Submit regulatory dossier, subsequent query resolution, and follow up.

• 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

• Regulatory/Quality Analysis

• Providing support and working in collaboration with PI’s at all sites

• 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

Location: Rem

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PATH is an equal opportunity employer. Every qualified applicant will be considered for employment.

PATH does not discriminate based on race, color, religion, caste, gender, sexual orientation, gender identity, genetic information, age, national origin, marital status, disability status, political ideology, military or protected veteran status, or any other characteristic protected by applicable federal, state, or local law.