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Senior Manager, International Regulatory Affairs

Boston, MA or REMOTE

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:

  • Plans and executes international product registration strategies for SaMD, IVD, CDx, RUO, LDT products
  • Collects, prepares and distributes required documents to ensure compliance with International Product Registration mandates, global Health Authorities and internal standards and requirements.
  • Manages content and accuracy of critical documents to meet health Authority requirements; these include Certificates and Manufacturing Licenses, US Certificate of Foreign Government (CFG), Letter of Authorization or Notification, and declarations in support of marketing applications.
  • Prepares supporting documentation and arrange for legalizations, as required by country regulations.
  • Maintains real-time knowledge of global product registration documentation obligations and changes
  • Maintains up-to-date knowledge of extensive and complex global product registration requirements, assessing and communicating impact for our business and products.
  • Proactively identifies risks and issues, and develops solutions related to assigned projects / countries in order to support product lifecycle ancillary documentation
  • Contributes to internal policy regarding country regulatory and policy changes as they relate to International Product Registration requirements
  • Write, analyze, and edit technical documents to support country-specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents. Work with other departments and communicate the submission requirements when documents are needed for regulatory submission.
  • Maintains international registrations per change management, keeping registrations up to date as products or regulations chang

Qualifications:

  • Bachelor's degree in Science, Engineering or related discipline
  • 5-7 years of relevant work experience. Experience in a medical or scientific environment is preferred.
  • Excellent skills to understand, document, and effectively communicate complex technical information (written and oral)
  • Knowledge of global regulatory requirements for in vitro diagnostic medical devices
  • Knowledge of global regulatory requirements for clinical trials and clinical laboratory activities
  • Excellent organizational and presentation skills
  • Must have a flexible mindset with the ability to work in a fast-changing environment
  • Ability to work independently with minimal supervision
  • Must be independent, self-motivated, organized, able to multi-task, and skilled in communication, facilitation, and collaboration

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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