Regulatory (RA/QA) Specialist

You know that strong digital health products only succeed when innovation and regulation move forward together. As Regulatory (RA/QA) Specialist at Luscii / OMRON DH, you are at the heart of that balance. In this role, you shape the regulatory and quality foundations that allow our products to scale internationally, while staying safe, compliant and future-proof. You will not just maintain a system; you will actively steer how regulatory and quality requirements are embedded into product development, decision-making and growth. This is a role for someone who enjoys being close to strategy and execution at the same time and who understands that smart regulatory leadership enables speed rather than slowing it down.

What makes this role particularly compelling is the breadth and impact of your mandate. You operate at the intersection of medical device regulation, software development, data and international expansion. From MDR and ISO 13485 to FDA and UKCA, you help define how Luscii navigates an increasingly complex regulatory landscape. As the RA/QA specialist at Luscii, you will work closely with product, engineering, security, privacy and clinical experts, translating regulatory requirements into practical, scalable processes. Your work directly influences how fast and responsibly we can innovate, enter new markets and expand our product portfolio. All while building and keeping OMRON Digital Health Quality Management System in line with regulatory requirements.

At Luscii, we believe digital health should create space for care: for patients, for healthcare professionals and for healthcare systems as a whole. Our technology supports hospitals, clinicians and patients with smart remote monitoring and digital care pathways. To make that possible at scale, regulatory excellence is not a checkbox but a core capability. As Regulatory Specialist, you help safeguard trust in our solutions while enabling growth. You join a mission-driven organization where quality, compliance and impact are deeply connected, and where your expertise directly contributes to better healthcare outcomes.

Looking ahead, Luscii is expanding internationally and evolving its product portfolio. We are preparing for broader global market access and exploring new use cases. This growth demands a scalable and future-oriented regulatory and quality strategy. We want to stay ahead of regulatory developments rather than react to them and we see regulation as an enabler of sustainable innovation. At Luscii, you will find an ambitious, collaborative environment where expertise is valued, ownership is encouraged and the impact of your work is tangible.

Your role

As Regulatory (RA/QA) Specialist, you take ownership of the regulatory and quality landscape within Luscii. In this role, you ensure that all applicable regulatory and quality requirements are in scope, implemented, maintained, and scalable in line with our product development and international growth ambitions. You act as PRRC and are responsible for the continuous development of our Quality Management System.

At the same time, you play a strategic role by anticipating regulatory changes, aligning them with business and product decisions and translating them into clear governance and practical processes. Moving and operating in different circles at Luscii, you will collaborate closely across teams and act as a connector between regulatory, quality, privacy, security and legal domains.

What you will be doing, among other things:

• Own, maintain, and continuously improve the QMS in line with ISO 13485, MDR, ISO 14971, and applicable MDCG guidance, acting as PRRC;

• Ensure audit readiness at all times by leading internal audits and supporting external audits and inspections;

• Establish and oversee post-market surveillance, PMCF, vigilance and non-conformity handling processes;

• Develop and own the regulatory strategy for international expansion, including FDA (SaMD), UKCA, MDSAP and future market access;

• Translate complex regulatory requirements into practical, scalable processes embedded in daily operations;

• Scope, assess and lead regulatory initiatives related to interoperability, data sharing, privacy and quality standards;

• Act as a cross-functional regulatory connector, ensuring alignment between medical device regulation, information security (including ISO 27001) and organizational resilience.

Why Luscii

Real impact, worldwide – At Luscii, your work helps transform healthcare on a global scale. From The Netherlands to America and from Africa to Japan, we empower healthcare professionals to guide their patients remotely. If you care about making a real difference, this is where your skills matter most.

No managers, just ownership – We believe in autonomy over hierarchy. That means no traditional managers. Everyone takes full responsibility, shares ideas openly, and drives real change, together.

Work smart, live well – We work four days a week. Because rest fuels creativity, and life outside of work matters too. Our rhythm is focused, efficient and deeply human.

Remote-first and flexible – Work from anywhere in The Netherlands. Join stand-ups from your kitchen table, collaborate with teammates across Europe, and meet up in person when it counts.

Learn fast, grow faster – Innovation in healthcare means always being curious. At Luscii, you’ll be part of a talented team that’s constantly learning, sharing knowledge, and pushing boundaries.

A culture that feels right – We build serious things, without taking ourselves too seriously. Expect fun, ownership, trust, and celebration, because great work deserves it.

Most important benefits

• Salary: € 6.500 - € 9.000 gross per month (based on 32 hours – that’s full-time at Luscii).

• Remote-first: Work from anywhere in The Netherlands. We stay connected through monthly in-person team days called Assemblii.

• Flexible setup: Create your own ideal workspace. Whatever works best for you - we’ve got you covered here.

• Culture of freedom: No managers, just ownership. We're organised as a Holacracy: think autonomy, transparency, and shared responsibility.

• Time for life: We work a 4-day week, Monday to Thursday. Focused, efficient, and human.

• Continuous growth: Access to courses, conferences, and the space to keep learning. Because you're already intrinsically motivated to stay sharp.

• Team spirit: You will join a close-knit and international team of ~75 colleagues who support each other and grow together.

• Fun matters too: Monthly activities, meaningful moments and a culture where joy is just as important as impact.

• Saving lives: Making a real impact on other peoples live by working on a software that actually makes a difference.

The ideal candidate…

… probably doesn't exist, but if you can tick most of the checkboxes below, please apply! We are looking for somebody who is comfortable in taking ownership and making well-considered decisions independently. You enjoy the autonomy to shape your work and responsibilities, while actively seeking collaboration and alignment with others. You know when to step up, when to involve colleagues and when to move forward decisively. Working independently does not mean working in isolation for you. You feel at ease being both a self-starter and a committed team player, contributing to shared goals while taking responsibility for your own domain. You value open communication, transparency and mutual trust.

• Several years of experience in regulatory affairs and QMS, so you’ve been working as Senior QA/RA or Regulatory Lead before in relevant environments with both operational and strategic challenges to work on;

• Demonstrable experience in leading MDD or MDR trajectories for software as a medical device;

• In-depth knowledge of ISO 13485, ISO 14971 and post-market requirements for medical device software;

• Proven ability to translate regulatory requirements into practical organizational designs and solutions;

• Strong affinity with international regulatory landscapes, data protection and interoperability;

• Comfortable operating both hands-on work & focus on strategy and vision building;

• You are open to working in a Holacratic organization and curious about our way of organizing work, roles, and responsibilities;

• English is our primary language for all internal communication at Luscii, so you're fluent in that language.

Looking into certifications and training, it would be incredibly helpful if you’ve finished relevant certifications (e.g. RAPS / RAC Devices) at the time of your application. Willingness and ability to build a formal competence profile through targeted training and certification is expected, please elaborate on this in your motivational letter too.

Please elaborate about your own knowledge, background and fit with the role and its requirements itself in your motivational letter. We’d love to hear and read about your own perspective on a role as such.

For now, we are looking for candidates who are already living and working in The Netherlands. Please only apply if you are already living and working in The Netherlands.

Interested? Apply now!

Would you like more information? Feel free to contact our recruiter Björn Bogerd via [email protected]

What does the recruitment process look like?

• Review of your cv and application, done by the recruiter;

• Phonecall with the recruiter, probably within a week after your application if we do see a potential match;

• Personality questionnaire to be filled in by yourself as preparation for the first digital interview;

• 1st role fit interview, in which we will discuss the position itself further and see how that aligns with your own background, interests and ambitions;

• A practical / technical assignment and the 2nd interview to dive deeper in to the technical and practical aspects of the position. Here we will discuss your reasoning and discuss your experiences further, based on both hypothetical and realistic examples;

• Cultural fit interview about working at Luscii, our culture, our way of working and the environment you might thrive best in.

It's quite a process, but we want someone to fit in well with our organisation and culture. All interviews will be done online and the whole procedure will be scheduled upfront to maintain momentum during the process.

For this role, we do not work with external agencies. However, if you know the perfect candidate, feel free to encourage them to apply directly.