Back to Job Listings

Regulatory Affairs Manager

PathAI Boston

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:

  • Driving regulatory strategy for IVD medical device compliance and for global registrations (Worldwide)
  • Completing submissions (Breakthrough Designations, 510(k)s, De Novos, IDEs, PMAs, PMA supplements, IVDR Technical Documentation)
  • Leading regulatory meetings and interactions, including FDA pre-submissions
  • Supporting clinical trial services and drug development tools (Biomarker Qualification)
  • Implementing processes for efficiency and effective regulatory compliance
  • Working with business development and biopharma partners on development of CDx devices
  • Engaging with CLIA diagnostics laboratory for early research and studies
  • Staying informed regarding new guidelines and regulations for successful implementation in the QMS, specifically regarding AI/ML and SaMD
  • 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, product, HFE, 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 impacting regulatory submission activities
  • Help build regulatory teams by collaborating with regulatory affairs teammates

 

Requirements:

  • 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) 
  • Minimum bachelor’s degree in an appropriate scientific or other related field, RAC certification preferred
  • 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. Your compensation is rounded out by a strong benefits package:

  • Flexible work hours, with work-from-home options available 
  • Three weeks of paid leave per year, an additional two weeks of sick time, plus extended holidays and team-approved leave
  • Ten days of 100% subsidized childcare per year
  • Healthcare, vision, and dental insurance plans (HMO or PPO), with voluntary add-ons available for dependent care, life, and accident coverage
  • Commuter benefit available for public transit or parking

Most importantly, you'll be doing important work with a team of people you'll genuinely 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.

PathAI does not accept unsolicited submissions from third-parties. 

With the rise of employment phishing scams, especially during the current COVID-19 situation, we ask candidates to be extra vigilant. Be careful about providing any kind of personal information, such as location, age, or financial information to recruiters who may be impersonating PathAI employees. PathAI does not require payment for interviews or for applicants to purchase their own work supplies for reimbursement.

 

#LI-Remote