Head of Regulatory Affairs

22 Sep, 2020

Jobs

Head of Regulatory Affairs

PathAI
Boston, MA/Austin, TX

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.

For us, it’s early days – a fast-growing, in-demand business and the need for a security team that helps keep us quick and nimble while protecting the sensitive customer and patient data we handle.

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 will be the direct liaison and lead strategist with the US FDA and all global regulatory authorities. 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 closely with other key Software as a Medical Device (SaMD) core team leaders including the Head of Quality and the Head of Clinical Affairs to develop and execute on PathAI medical device strategies.

Responsibilities

  • Preparation & execution of product premarket authorizations/registration, including but not limited to: PMA, 510(k) and CE mark.
  • Management of 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.
  • Direct liaison with global notified bodies (US FDA, Health Canada, EU, etc.), managing relationships to ensure all inquiries and requests are handled promptly and with care
  • Key regulatory point of contact for critical partnerships with pharmaceutical and commercial laboratories.
  • Remain current in all globally regulatory happenings that may impact PathAI and ensure effective communication of such activities to PathAI senior management.
  • Work as a recognized industry leader and play an active role to shape regional and global regulatory guidances and standards.
  • Provide critical regulatory input in all 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.
  • Provide guidance on new product evaluations, drawing on expertise submitting to and working with governing bodies
  • Directly manage and lead a team of regulatory affairs managers, specialists and associates and actively engage in career growth and development as well as performance management.

Requirements

  • 8 years or more experience in domestic and international quality management and/or regulatory affairs for software controlled medical devices is a must.
  • Experience in US Class III (high risk) medical device development. Diagnostic instrumentation and/or diagnostic image analysis products is a plus.
  • Prior experience writing PMA,  510K and technical files for CE certification
  • 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
  • People management experience
  • Excellent and adaptable analytical, organizational and communication skills
  • BS Degree in engineering, physical, or life science (Advanced degree preferred)
  • Prior experience and success in working in a startup or small company strongly preferred
  • Prior experience in Clinical Affairs ensuring that study designs meet regulatory requirements a plus

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
  • 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
  • Convertible sit-stand desks
  • Weekly in-office yoga classes

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.

Learn more here

Job posted: 2020-09-22