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As a Software Developer at Corify, you will propose solutions to technical challenges commonly associated with GUI development to be evaluated by cross-functional teams. You will assist in the design, development, documentation, integration and testing of high-quality software for medical devices. This includes developing intuitive, traceable and efficient code.
Be a part of a team where you will:
- Assist in incorporating source code, with associated unit and integration tests, into Continuous Integration and Continuous Deployment frameworks.
- Translate user needs and engineering, clinical, marketing and regulatory inputs into defined product specifications and mockups.
- Provide insights into emerging technologies and uncovering, identifying, and creating business and product opportunities for our clients during strategic conceptualization efforts
- Guide design teams and our clients through the concept selection decision making processes to ensure that technical considerations factor into alternative narrowing and selection.
- Report to CTO.
Regulatory affairs and quality manager
As Regulatory affairs and Quality manager, you will support all the related activities for the Corify’s products, including but not limited to collecting and summarizing regulatory intelligence, performing regulatory assessments, participation in project teams, providing input for regulatory submissions, and managing the compilation and review of all submissions for completeness and quality.
What we need:
- Manage regulatory projects and closely collaborate with Clinical, Regulatory Operations
- Provide tactical support for the timely preparation, editing and review of submissions, including regulatory agency Meeting Requests and Briefing Documents, IND/CTA amendments, original BLAs and international Marketing Authorization Applications and their respective amendments/supplements.
- Coordinate and manage regulatory submission documents (e.g., cover letters, Meeting Requests, Meeting Briefing Packages, etc.) to produce submission ready content.
- Manage the quality, accuracy, compliance with internal and external standards, and the timely production of submission documents using manual and electronic document management systems.
- Assist with logging, tracking and filing of correspondence with regulatory authorities and ensuring that no commitment remains unduly outstanding.
Clinical Project Manager
As a Clinical Project Manager at Corify, you will design, plan and supervise the implementation of the clinical trials for our products, according to applicable regulations. You will define effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
Be a part of a team where you will
- Develop consent forms and other required documentation for their approval by Ethics Committees.
- Coordinate new protocol submissions, renewals, revisions and reports to applicable regulatory agencies.
- Coordinate CER drafting.
- Supervise the implementation of and adherence to study protocol, and providing support in analyzing the data. Ensuring that the study protocols are conducted in compliance with applicable regulations.
- Keep updated the technical files of our devices regarding their clinical evaluations
- Train clinical research team members and evaluating their performance.
- Reporting to CEO.