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Ketryx

SaaS platform for regulated medical software

Head of Operations

Full-Time
$175k - $200k/yr+ Variable compensation + Equity options
Senior, Expert
Boston, MA, USA
HybridFour days on-site per week are required, with quarterly travel to the Vienna office.
People & HRCompensation & Benefits, HR Generalist & Employee Relations

About the job

Requirements
  • At least 8 years of experience in human resources or People Operations, including at least 3 years leading the function or a major pillar, especially in high-growth startups.
  • Experience scaling a company through significant headcount growth.
  • Ability to operate without a large team or established playbook by building and then running the required systems.
  • Strong recruiting judgment and the ability to assess engineering and go-to-market talent markets and partner credibly with engineering leaders.
  • Demonstrated ownership of compensation and leveling design.
  • Multi-country employment experience across the United States and European Union, or clear evidence of being able to get up to speed quickly.
  • Sound judgment in ambiguous and confidential situations, with the directness to bring difficult news to the leadership team early.
  • Strong opinions on effective approaches, willingness to try new approaches, and a network of People leaders for broader questions.
Responsibilities
  • Ensure company values are incorporated into daily working practices and create an environment where people can execute at a world-class level.
  • Own performance management, including goal setting, review cycles, calibration, and subsequent difficult conversations.
  • Build manager capability across a team with many first-time managers.
  • Run engagement measurement and act on its results.
  • Own the human resources information system, payroll, benefits, onboarding, and offboarding across United States and European entities.
  • Build processes where they remove friction and resist processes where they do not.
  • Build a leveling framework, compensation bands, and an equity philosophy across engineering, go-to-market, and general and administrative functions.
  • Maintain employment compliance across multiple countries and states as the company expands.
  • Run market benchmarking and annual compensation cycles in partnership with Finance.
  • Build a hiring engine that consistently attracts senior engineers, go-to-market talent, and life sciences domain experts in a competitive market.
  • Partner with leadership on headcount planning and sequencing, including what to hire, when to hire, and why.
  • Improve interview design, structured evaluation, and candidate experience so hiring decisions are consistent and defensible.
  • Develop the company's employer brand to attract high-caliber talent.
Desired Qualifications
  • Experience supporting distributed teams across United States and European time zones.

About the company

Ketryx offers a SaaS Connected Lifecycle Management platform for regulated medical software. It guides the full lifecycle from planning through verification and maintenance, ensuring compliance with FDA, IEC 62304, GMP, ISO 13485, and CFR 21 Part 11. The platform integrates traceability, documentation, Jira, and SBOM management to streamline development, quality, and compliance. It targets MedTech teams from startups to large enterprises, aiming to reduce compliance risk and development costs while speeding time to market.

Company Size

51-200

Company Stage

Series B

Total Funding

$57.1M

Headquarters

Cambridge, Massachusetts

Founded

2021

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Simplify's Take

What believers are saying

  • Ketryx raised $39 million on September 4, 2025, led by Transformation Capital.
  • Ketryx announced MCP beta on March 31, 2026, embedding compliance into AI workflows.
  • Four of five top Fortune 500 MedTech companies now run on Ketryx.

What critics are saying

  • FDA warning letters on AI usage in 2026 punish weak human oversight and validation.
  • Siemens Healthineers, Veeva, and Jama can bundle compliance into existing enterprise contracts.
  • If Ketryx loses trust in auditability, regulated buyers stop deployments immediately.

What makes Ketryx unique

  • Ketryx launched validated AI agents on May 1, 2025, for regulated medical workflows.
  • Ketryx holds ISO 13485, IEC 62304, ISO 27001, and SOC 2 Type II.
  • Ketryx serves Meta Reality Labs, Flo Health, DeepHealth, HeartFlow, and Fortune 500 MedTech.

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Benefits

  • Hybrid Work Options
  • Unlimited Paid Time Off
  • Stock Options

Growth & Insights and Company News

Headcount

6 month growth

2%

1 year growth

9%

2 year growth

7%
VentureFizz
Sep 30th, 2025
Hiring Unlocked: Ketryx Event Video - Company Details, Jobs, Culture, and More

Recently, Ketryx announced a $39M Series B round of funding led by Transformation Capital, with participation from existing investors including Lightspeed Venture Partners, MIT's E14 Fund, Ubiquity Ventures, and 53 Stations.

FinSMEs
Sep 4th, 2025
Ketryx Raises $39M in Series B Funding

Ketryx, a Cambridge, MA-based AI-powered compliance platform helping life sciences companies ship safer products faster, raised $39M in Series B funding

PR Newswire
Sep 4th, 2025
Ketryx Raises $39M Series B Round to Power the Future of Regulated Artificial Intelligence for Life Sciences

Ketryx raises $39M Series B round to power the future of regulated artificial intelligence for life sciences.

SiliconANGLE Media
Sep 4th, 2025
Ketryx raises $39M to help medical device makers ship safer products faster

Ketryx Corp., a company transforming product lifecycle development and compliance for medical device makers with artificial intelligence, today announced it has raised $39 million in a Series B funding round led by Transformation Capital.

TechIntelPro
May 2nd, 2025
Ketryx Launches First Validated AI Agents to Accelerate Safety-Critical Product Development

Ketryx launches first validated AI Agents to accelerate safety-critical product development.