Compliance Analyst, Healthcare & Life Sciences Practice
DataArt’s specialists are developing tailor-made technological solutions for clients in the healthcare industry, such as EHR (electronic health record), CTMS (clinical trial management system), mobile applications for patients etc. Our clients include technological companies, hospitals, laboratories, pharmaceutical companies, CRO (contract research organization) from the US and Europe.
The Healthcare & Life Science team is searching for a compliance specialist who will be responsible for monitoring products for compliance with industry standards.
- Creates strategies to align the Software Development Process, so that processes and products (as a result) meet the selected compliance standards;
- Designs and conducts product risk analysis, keeps all related records;
- Organizes validation of project-specific software;
- Organizes reviews and acceptance meetings, updates documentation respectively. Tracks the resolution of issues arising from these meetings;
- Controls the private data is kept intact and secure;
- Implements risk control measures;
- Creates product acceptance criteria;
- Makes sure that all teams are trained appropriately for product development and that training materials are kept up to date.
- At least a bachelor’s degree (engineering degree is preferred);
- Software validation experience;
- Knowledge of techniques for conducting Product Risk Analysis;
- Ability to read, analyze, and interpret technical reports, technical procedures, standards, and regulations;
- Knowledge of the basics of software development methods and software testing;
- Goal-oriented, efficient, organized, and strong analytical skills;
- High emotional intelligence and great communication skills;
- Intermediate English (minimum);
- Proficient in Microsoft Office (MS Word, Excel, Visio).
Would be a plus
- Problem-solving attitude;
- Good team player;
- Experience of working with ISO quality system, US FDA Quality System Regulation, and relevant international standards;
- Knowledge of ISO 14971, ISO 9001, and ISO 13485 international standards;
- Experience of working in healthcare and/or with medical devices.