JOB DESCRIPTION

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.

Responsibilities: 

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 and for global registrations
  • 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, including review of design documentation
  • Identify and help resolve product development issues which regulate to regulatory submission activities
  • Help build regulatory teams by collaborating with regulatory affairs teammates

Requirements: 

Minimum bachelor’s degree in an appropriate scientific or other related field, RAC certification preferred

  • At least 5 years experience, preferably 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, 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
  • Strong collaborative and team spirit

Benefits: 

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.

QUALIFICATION/REQUIREMENT
JOB LOCATION Boston, MA, US
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