Head of Regulatory Affairs

| Greater Boston Area
Apply now
By clicking continue you agree to Built In’s Privacy Policy and Terms of Use.

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.


Read Full Job Description
Apply now
By clicking continue you agree to Built In’s Privacy Policy and Terms of Use.

Technology we use

  • Engineering
    • JavascriptLanguages
    • PythonLanguages
    • VueJSLibraries
    • DjangoFrameworks
    • PostgreSQLDatabases

Location

We're right in Fenway! One of our perks is Red Sox tickets.

An Insider's view of PathAI

What kinds of technical challenges do you and your team face?

Automating and auto-scaling a generalized machine learning workflow that takes pathologists from a slide medical image to a clinical prediction

Mariel

Senior Platform Engineer

What are PathAI Perks + Benefits

PathAI Benefits Overview

PathAI offers a standard benefits package (health insurance, 401k, stock options) in addition to some fun perks, listed below!

Health Insurance & Wellness Benefits
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
PathAI covers 85% of the premium for individuals and 75% for families
Retirement & Stock Options Benefits
401(K)
Company Equity
We don't offer a 401(k) match yet because we're still in Series A funding round. We'll be rolling it out soon, though!
Child Care & Parental Leave Benefits
Generous Parental Leave
All employees receive a free membership to care.com to help with childcare needs
Flexible Work Schedule
PathAI employees make their own schedule (with their manager's approval)
Remote Work Program
We are very remote-friendly
Family Medical Leave
Vacation & Time Off Benefits
Generous PTO
We do three weeks PTO
Paid Holidays
Paid Sick Days
Perks & Discounts
Beer on Tap
Not on tap, but in the fridge. We have green tea, iced coffee, and kombucha on tap, though!
Casual Dress
Commuter Benefits
Company Outings
We have season tickets for the Red Sox!!
Game Room
Our game room has a PS4!
Stocked Kitchen
Fruit snacks, milano cookies, seaweed snacks, fresh fruit, pop tarts, cereal, kind bars, etc. You can also request any specific snacks you would like on hand by asking our front desk associate
Some Meals Provided
We do a catered lunch for the entire company every Friday
Happy Hours
Whiskey Wednesday!!!
Parking
Relocation Assistance
Professional Development Benefits
Job Training & Conferences
More Jobs at PathAI20 open jobs
All Jobs
Finance
Data + Analytics
Design + UX
Dev + Engineer
Internships
Legal
Operations
Product
Sales
Apply now
By clicking continue you agree to Built In’s Privacy Policy and Terms of Use.
Save jobView PathAI's full profileSee more PathAI jobs