Quality & Regulatory Product Lead
About Curoflow
At Curoflow, we’re redefining how healthcare works for patients and providers across Europe. Our all-in-one digital platform – a “Shopify for healthcare” – enables clinics to deliver seamless, secure, patient-focused healthcare. With customers in 7 countries and game-changing product launches on the horizon, we are looking for a Quality & Regulatory Product Lead ready to grow with us.
This isn’t just another quality role. It’s your chance to take ownership early, shape healthcare’s digital future, and grow into a managerial position.
We don’t do things the way many does. You will notice this when you meet our team. We are a growing group of 27 individuals split over two offices, striving to make global impact. We are determined, eager and willing to do what it takes to build the next great healthtech company made in Sweden!
And let’s be honest. Curoflow is a start-up. If you’re looking for a hefty pay rise or a strict 9-5 job, Curoflow is not for you. We want people who are willing to give that bit extra and in return get that bit extra in terms of stock options, a good salary, and a fantastic mission to join.
As a fast‑growing health‑tech company, we try to combine startup energy with the structure required in a regulated environment. With us, you will work closely with product, engineering, and leadership, and play a key role in how we continue building for the future: new product classes, artificial intelligence, and global expansion.
We are growing fast - and with us, so can you!
Your Role – What You Will Do
As a Quality & Regulatory Product Lead, you will primarily work with quality, regulatory affairs, and compliance for our medical device platform. At the same time, you will have a product‑oriented role where you support the product team with requirements work, market and user insights, and international expansion.
Your responsibilities include:
Quality & Regulatory Compliance (main focus):
• Establish, structure, and maintain documentation in accordance with MDR and current product classification.
• Develop compliance strategies, including for future product classes and AI‑based solutions.
• Develop and implement processes and procedures in the Quality Management System (QMS) based on relevant ISO standards and MDR.
• Support the development team in implementing standards, processes, and documentation.
• Work with Post‑Market Surveillance (PMS): deviations, complaints, CAPA, traceability, documentation and reporting, as well as internal/external audits.
• Serve as the point of contact toward Notified Bodies and ensure readiness for audits and certification processes.
• Drive activities related to product registration, regulatory analyses, and compliance in connection with international expansion.
• Contribute to CSR initiatives, environmental objectives, internal policies, and KPIs related to quality and compliance.
• Produce and present quality data and analyses for internal and external stakeholders.
• Monitor product quality and performance in production, identify improvement areas, and implement measures to enhance safety, quality, and user experience.
Product & Cross‑Functional Collaboration
• Support the product team with requirements gathering, user insights, and documentation of features and integration needs.
• Participate in release cycles, including testing, verification, and validation of new features and improvements.
• Drive cross‑functional improvement initiatives within quality, safety, and product processes.
• When needed, support the customer team in handling support cases to capture quality‑related information and ensure correct corrective actions.
Who You Are – Qualifications
Required:
• Academic degree in engineering, law, life sciences, or a related field.
• At least 3 years of experience in quality and regulatory work within medical devices or healthcare software.
• Experience working with quality systems, documentation, CAPA, and audits.
• Fluency in English, spoken and written. Swedish is a big plus.
• Interest in product work — requirements management, market/user insights, and international perspectives.
• Ability to work in a structured, independent, and highly accurate manner.
Meriting:
• Experience working with AI (preferably in medical device or regulated environments).
• Experience in product management or product‑adjacent roles.
• Experience with international market introduction and regulatory work in new markets.
• Experience with MDR/MDD (preferably within software).
• Experience with or understanding of software development.
Why Curoflow?
• You will be part of a fast‑growing health‑tech company building the healthcare platform of the future.
• Significant opportunity for impact — both in daily QA work and in shaping the long‑term product direction.
• Personal growth opportunities with the aim of you becoming the ”head of quality”.
• The platform is CE‑marked and used internationally: you will contribute to global expansion and scaling.
• The combination of QA/regulatory work + product collaboration makes this role unique and broad.
• A team passionate about improving healthcare for millions of people.
Working conditions
Full time
Location: Stockholm, Scheelegatan
Work from home policy: 1 day/week
Benefits besides salary include, wellness grants, occupational pension, flexible working hours and the possibility of receiving equity options
Send in your application today! We're eager to meet you!
- Locations
- Stockholm
- Remote status
- Hybrid
Stockholm
An usual, unusual place to work
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An office with the right feel
We sit together on 200 square meters spread over two floors. Looking for light and airy? The upper floor's sloping ceiling with windows that span over the entire office ceiling allows for great daylight all through the day. You'll find ergonomic office furniture and accessories at your disposal. Want to work out before work or at lunch? Borrow one of our changing rooms where you can shower and change.
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Well-being
Good health is the key to many things. That's why we offer a wellness grants to all employees. Feel like taking a 15-minute stroll along the water front or maybe just relax for a bit? Borrow one of our downstairs rooms and why not try our magical massage chair. Fruit is also good for your health - so we make sure it's available every day.
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Pension and insurance
We want you to have good benefits when you join our team. We therefore offer an occupational pension and insurance to all employees.
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Hanging out
Even the soul needs its lubrication and we often enjoy each others company over a Swedish fika. At least once ayear we go on a joint trip for team building and activities. This year, one of the trips will take us to Belgrade for example. Many of us also like to hang out outside office hours from time to time, going bowling, grabbing a drink or whatever fits the season.
A pleasant workplace
Do you also want to come to work and feel that you are making a difference? With us, you will be an important part of a team that works and have fun together. We believe that a pleasant workplace with direct communication, short decision paths and an inviting environment, provides the conditions for a job to enjoy and look forward to! Join us and make our workplace much more than just a place to work.