About Proscia
Pathology is at the center of medicine, and is undergoing a profound transformation as the final frontier of digitization in healthcare. We started Proscia to accelerate pathology’s transition from microscope to images, and to use that data to change the way we think about cancer. We can’t change medicine alone. That’s why we’re looking for curious thinkers. Big dreamers. Developers, evangelists, pathologists, and scientists. Exceptional talent to help us use great power for good and advance humankind.At Proscia, we push the limits of medicine and technology, solving problems the world has never solved before.
We build software used by thousands of scientists and pathologists, who work on the front lines of fighting big enemies, like cancer, for patients around the globe. To accelerate our vision, Proscia has raised capital from great investors like Highline Capital Management, Emerald Development Managers, Triangle Peak Partners, Alpha Intelligence Capital, Scale Venture Partners, Hitachi Ventures, Flybridge, and more.About the roleThe Senior Regulatory Affairs Specialist ensures that Proscia’s diagnostic imaging products are developed, distributed, and monitored in alignment with regulatory requirements in multiple geographies.
Manages global device registrations and authorizations to meet business objectives and supports new product development.Key Responsibilities
- Prepare and maintain domestic and international regulatory filings
- Determine market authorization requirements in assigned geographies
- Provide input and technical guidance on regulatory requirements to product development and operations teams including review and approval of relevant documentation
- Guide product development teams by identifying applicable regulations/standards and assisting with interpretation and compliance. Maintain compliance checklists.
- Assess the regulatory impact of medical device design changes
- Support product safety evaluation and reporting as required by country regulation
- Interface with regulatory agencies, in-country representatives, and distribution partners as needed to maintain market access and expand to new markets
- Assess the potential impact from new guidance and regulations
- Other duties as assigned
What are we seekingRequirements
- Authorization to work in the U.S.
- BS degree in a relevant field. BS in Engineering or Science preferred.
- 5+ years of medical device experience. SaMD experience preferred.
- Ability to identify and apply medical device regulations, standards, and regulatory guidance.
Preferred
- Experience with SaMD, diagnostic imaging, pathology, companion diagnostics, digital biomarkers, molecular diagnostics.
- Experience managing or leading regulatory submissions (e.g. FDA 510(k) and EU IVDR technical documentation) and/or international registrations.
Beyond Just WorkAs a company in the healthcare field, we want our people to be happy and healthy, in and out of the office. In addition to competitive pay, we ensure everyone on our team is supported with savings, schedule, and insurance options that promote long-term health and personal growth.Our office environment is designed for creativity and agility: with walls as notepads and couches for collaboration. We’re located in the heart of Philadelphia, with views of the city atop the train station so you can spend your time focusing on what matters most.
Yes, we have the free food, gourmet coffee, craft beer, and wellness rooms —but you’ll come for the challenge, the camaraderie, and the opportunity to do bold work.At Proscia, we don’t just accept differences — we celebrate them, we support them, and we thrive on them for the benefit of our employees, our products, and our community. Proscia is proud to be an equal opportunity workplace.
