Regulatory Affairs Manager
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 professional with at least 5 years experience 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.
If you're the right candidate, you'll be exercising all the skills you have in this role, and building new ones along the way, including:
- Completing FDA pre-submissions requests
- Completing submissions (510(k)s, PMAs, PMA supplements), by building the technical files as well as the design dossiers and authoring summaries
- Contributing to regulatory strategy for medical device compliance
- Staying informed regarding new guidelines and regulations for successful implementation in the QMS
- Reviewing and improving the QMS based on FDA QSR and the harmonized standards ISO 13485, ISO 62304, ISO 62366 and ISO 14971
- Serving 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
- Minimum bachelor’s degree in an appropriate scientific or other related field, RAC certification preferred
- At least 5 years experience 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)
- Ability to work autonomously to problem-solve, demonstrates excellent analytical skills
- Knowledge and practical understanding of ICH Guidelines regarding GxP, as well as MDDR and IVDR
- Experience 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
- Knowledgeable of effective and compliance engineering and communication practices to enable technical teams
Our employees come in all shapes and sizes, but to be successful in this role with us, you'll at least need:
- Experience. You've been around the block a more than a couple times, typically via five years of work in this field. Currently you are a skilled regulatory affairs manager who is used to working autonomously, but if you are a Senior Associate who is convinced you should have been a manager, you are welcome to show us you are ready to take on this challenge.
- Education. Generally, a college degree is really helpful in working with our team on this kind of work. But feel free to convince us if you're the exception.
- An insatiable intellectual curiosity and the ability to learn quickly in a complex space and help to shape the regulatory team.
For the right candidate, we'll offer a competitive salary plus equity and training. 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 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.