Responsibilities
- Contribute to developing and implementing global regulatory strategy and roadmaps through a deep understanding of the competitive market landscape, initiatives, and product
- Responsible for the planning, coordination, preparation, and completion of document packages for regulatory submissions to the US, EU, Canada, Japan, etc. (e.g. pre-submissions, 510k) and building the technical files as well as the design dossiers and authoring summaries
- Participate in meetings with the FDA and other 3rd party external regulatory agencies
- Stay informed regarding new guidelines and regulations for successful implementation in the QMS
- Review and improve the QMS based on FDA QSR and the harmonized standards ISO 13485, ISO 62304, ISO 62366 and ISO 14971
- Serve as the consultant for engineering, manufacturing, and clinical teams throughout the design control process; offering regulatory expertise during design input & output creation, verification, validation, design transfer, pre-clinical, and clinical testing, including review of design documentation to meet regulatory compliance throughout the full life cycle of the device, including defect and complaint reviews for program teams, provide guidance to the team on risk assessment and required corrective actions to meet regulatory requirements
- Identify and help resolve product development issues which regulate to regulatory submission activities
- Create an environment of positive feedback, and use professional concepts and company objectives to resolve complex issues in creative and effective ways
Requirements
Minimum bachelor’s degree in an appropriate scientific or other related fields, RAC certification preferred
- At least 2 years experience, of which at least 1 year in the regulatory environment of the Software Medical Device industry with excellent knowledge of the regulations for design of Software as a Medical Device (SaMD)
- Experience with successful preparations and submissions packages for registration purposes
- Experience in design control processes
- Ability to work autonomously to solve problems and demonstrates excellent analytical skills
- Knowledge and practical understanding of ICH Guidelines regarding GxP, preferably also MDR and IVDR
- Skilled in cross-functional project management in a regulated industry, especially in discussing controversial topics such as device risk, device classification, including MDDS, and human factors studies
- Knowledge of effective and compliant engineering and communication practices to enable technical teams
- Ability to work under tight timelines
- Being persistent and having strong collaborative and team spirit skills.