DataArt is a global software engineering firm. With over 25 years of experience, teams of highly-trained engineers around the world, deep industry sector knowledge, and ongoing technology research, we help clients create custom software that improves their operations and opens new markets. DataArt started out as a company of friends and has a special culture that distinguishes it from other IT outsourcers.
DataArt’s Healthcare & Life Sciences division is looking for a Quality & Regulatory Affairs Manager who wants to contribute to our further growth and maturity in the area of Software as a Medical Device (SaMD). If you are eager to push medical projects forward and bring regulatory-compliant apps to EU and US markets, we welcome you to our team.
As a Quality & Regulatory Affairs Manager you will work as our internal expert for regulatory and quality management topics in many Healthcare & Life Sciences projects with different approaches. You will get in touch with a lot of people in the industry and help them to combine regulatory affairs and agile software development.
- Drive establishment, certification and further development of DataArt’s Quality Management System in the area of Software as a Medical Device (SaMD)
- Monitor and assess international Regulatory developments (e.g. FDA and EU guidelines) related to the company’s projects. Taking ownership in implementing new regulatory requirements in the Quality Management System, evaluate and improve it
- Work closely with the management and project teams to ensure the delivery of regulatory compliant medical software products to our clients (including the creation and maintenance of the necessary regulatory documents)
- Consult clients in all aspects of regulatory compliance related to SaMD
- Collaboration with corporate functions (HR, IT, sales, etc.) in accordance with company’s QMS
- Internal (DataArt teams) and external (DataArt clients) consultations in all aspects of medical device regulatory compliance
- Drive preparations and passing through internal and external audits, communicate with external auditors
- Degree preferable in engineering, (medical) technology, life sciences or comparable qualifications
- Understanding principles of Software Development Life Cycle (SDLC) and Agile methodology
- Expertise in Software as a Medical Device (SaMD) and related regulations and guidance documents in US and Europe. For example, 21 CFR part 820 and related FDA guidance documents, Medical Device Regulation (MDR/IVDR), EU guidance documents, IEC 62304, ISO 13485, ISO 14971, etc.
- Fluent in English (German would an asset)
Nice to have
- 5+ years of experience working in the area of custom software development with US and/or EU companies
- Structured way of thinking with accuracy and attention to details
- High independence and hands-on mentality
- Analytical thinking, strong analysis and documentation skills
- Good team player and communication skills