Regulatory Affairs Manager

| Greater Boston Area
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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. 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.


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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
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