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Head of Regulatory Affairs

Boston, MA

Who We Are

 

PathAI is on a mission to improve patient outcomes with AI-powered pathology. We are transforming traditional pathology methods into powerful, new technologies. These innovations in pathology can help accelerate drug development, improve confidence in the accuracy of diagnosis, and get life-saving therapies to patients more quickly. At PathAI, you'll work with a diverse and talented team of people, who are dedicated to solving complex problems and making a huge impact.

Where You Fit 

PathAI is seeking a Head of Regulatory Affairs (Director/Sr. Director) to join the ranks of its growing leadership team of medical device development professionals. The Head of Regulatory Affairs would have an opportunity to join a high growth company and  be accountable for all aspects of regulatory development and implementation, working closely with other senior management to harmonize those strategies with the overall long-term goals of the company.. The successful candidate will also provide guidance on new product evaluations and business development as PathAI diversifies its product line. The Head of RA will work cross functionally to develop and execute on PathAI medical device strategies.

What You’ll Do

  • Preparation & execution of product premarket authorizations/registration, including but not limited to: PMA, 510(k), UKCA, and IVDR.
  • Provide critical regulatory input in all drug development tool and medical device development activities including design and development planning, risk and hazards analysis, testing schemes, usability and human factor testing, verification, analytical and clinical validations.
  • Work cross functionally consistently to provide guidance on new product evaluations and regulatory pathways, drawing on expertise submitting to and working with governing bodies and considering PathAI business strategy.
  • Responsible for PathAI relationships with regulatory counterparts within biopharma partnerships  and  global notified bodies, cultivating relationships and ensuring all inquiries and requests are accurately and promptly responded to.
  • Work as a recognized industry leader and play an active role to shape regional and global regulatory guidances and standards.

 

What You Bring 

  • 8 years or more experience in domestic and international regulatory affairs for software controlled medical devices is a must.
  • Experience in US Class III (high risk) medical device development. 
  • Prior experience writing PMA, 510K and technical files for CE certification
  • BS Degree in engineering, physical, or life science (Advanced degree preferred)
  • Strong interpersonal and relationship building skills, with special emphasis on the ability to effectively execute projects and provide guidance involving multiple internal and external stakeholders and decision makers
  • Excellent and adaptable analytical, organizational and communication skills
  • Prior experience in Clinical Affairs ensuring that study designs meet regulatory requirements a plus
  • Prior experience with in vitro diagnostics and/or diagnostic image analysis products is a plus.

 

We Want To Hear From You

At PathAI, we are looking for individuals who are team players, are willing to do the work no matter how big or small it may be, and who are passionate about everything they do. If this sounds like you, even if you may not match the job description to a tee, we encourage you to apply. You could be exactly what we're looking for. 

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.