Compliance & Operations Lead
AI in mental healthcare only works if it's trusted, and trust runs on proof: certifications, audits and processes that hold up under scrutiny. We're looking for the person who owns that proof. You'll lead our certification track under the medical device regulation (MDR), keep ISO 27001 and NEN 7510 alive in how we actually work, and build the internal operations of a company that's growing every week. Detail-oriented enough to satisfy an auditor, pragmatic enough for a startup.
Our platform already supports mental health professionals with session reports and documentation, and we're growing into diagnostics and treatment. Every week, new care organizations join.
What you'll do
What do you bring?
What we're building
At Ontzorgd we build AI software for mental healthcare: from automatic session reports to a platform that gives clinicians meaningful insight into their clients' progress. Today we save clinicians 3 to 4 hours of admin time a week; next, we want to help improve the care itself. That next step means medical device regulation, and it means someone who makes compliance a strength instead of a brake.
Where we stand right now
ISO 27001 and NEN 7510 are in place and need an owner who keeps them real. The MDR track lies ahead: scoping, technical documentation, quality management system, notified body. Operations is small today and growing steadily, and it stays relevant even in a world where MDR falls away. You'd be the first person fully dedicated to this, with the whole team around you.
A day in the life
Technical documentation, risk files, QMS records: you keep the proof current so an audit is a formality, not a fire drill.
Build an AI workflow that fills the compliance register, instead of filling it in yourself.
A privacy officer has questions about our data flows. You answer them plainly, and know when to pull in an engineer.
New feature on the roadmap? You're at the table early, so compliance shapes the design instead of blocking the release.
Billing, HR, contracts: small things done well, and set up to survive the next growth spurt.
Team getaways, days out on the water and other plans that have nothing to do with audits.
Okay. Maybe not every day. Audits, thankfully, are not a daily event.
What do we offer?
Gross per month, competitive and depending on your experience.
The application process
An informal conversation about who you are and whether it clicks.
A practical case: where would you start with our MDR certification track?
Does it click on both sides? Then we make you an offer.
We put the terms of employment on paper together.
Ready to join?
Send your CV or LinkedIn profile to binke@ontzorgd.ai. Tell us briefly what draws you to this role, and describe one process, audit or certification you took ownership of: what state it was in, what you changed, and how you knew it worked.
.svg)
