Senior Regulatory Affairs Software Specialist
Machine learning is eating the world. At PathAI, we're applying it in amazing ways to pathology, healthcare, and detecting cancer and other diseases. We're applying our work to drug development, the clinical space, and as a global health initiative. Since it's early days for us, there's a lot of work to do and a lot of great product to build, and ensuring regulatory compliance is critical to the success of everything we aspire to do.
We're looking for a regulatory affairs Medical Device professional with at least 5 years experience, of which at least 1 year in the Software Medical Device industry. RAC certification is preferred. As we are expanding our business and products, we are building the regulatory and clinical affairs team. In this role, you have the opportunity to contribute to growing the team and to developing your own challenging rewarding career path.
The Senior Regulatory Affairs SW Specialist (Sr. RA specialist) is responsible for the coordination and preparation of regulatory plans and document packages for regulatory submissions (FDA, Health Canada, EU, Asia, etc). The Sr. RA specialist also provides strategic input during product creation process and contributes to the department’s overall regulatory strategy plan. At PathAI, the Sr. RA Specialist cooperates closely with Product Development, Product Management, Machine Learning and Clinical Affairs.
- Contribute to developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative 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, 510(k)s, PMAs, de novo’s, Product Reports/Supplements) and building the technical files as well as the design dossiers and authoring summaries
- Participate in meetings with FDA and other 3rd party external regulatory agencies
- Contributing to regulatory strategy for medical device compliance and for global registrations
- 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
- Help build regulatory teams by collaborating with regulatory affairs teammates
- Create an environment of positive feedback, and use professional concepts and company objectives to resolve complex issues in creative and effective ways
Minimum bachelor’s degree in an appropriate scientific or other related field, RAC certification preferred
- At least 5 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 problem-solve, 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
- An insatiable intellectual curiosity and the ability to learn quickly in a complex space and help to shape the regulatory team
- Ability to work under tight timelines
- Being persistent and having strong collaborative and team spirit skills.
For the right candidate, we'll offer a competitive salary plus equity. We have a strong benefits package, including heavily-subsidized health, dental, and vision insurance plans to keep you in peak shape. It's rounded out by:
• Flexible work hours
• Three weeks of paid leave per year, plus holidays and extended leave
• Convertible sit-stand desks
• Your choice of computer equipment
• Free lunch on Tuesdays and Fridays
• Snacks and drinks in the office – which currently include a mountain of Milano cookies and cold brew coffee and green tea on tap.
Most importantly, you'll be doing important work with a team of people you'll enjoy spending the day with.
PathAI is an equal opportunity employer, dedicated to creating a workplace that is free of harassment and discrimination. We base our employment decisions on business needs, job requirements, and qualifications — that's all. We do not discriminate based on race, gender, religion, health, personal beliefs, age, family or parental status, or any other status. We don't tolerate any kind of discrimination or bias, and we are looking for teammates who feel the same way.