Work at Boule

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Boule is a fast growing and innovative company that develops, manufactures and sells leading systems for routine analysis of blood in human and veterinary health care environments.<br>What you are joining is a company that takes great pride in its products as well as company vision, improving health for everyone everywhere.<br>We are proud of our history, dating back to 1969. More importantly, we 
challenge ourselves to create greater impact in the 
future.&nbsp;

About Us

Mavericks don't blindly follow industry norms. They critically evaluate existing practices and propose alternative approaches. Their willingness to question assumptions leads to breakthroughs.

Independent Thinking

Effective mavericks exhibit strong leadership. They make tough decisions, communicate a clear vision, and inspire their teams. Decisiveness is essential for navigating uncharted waters.

Decisive Leadership

Mavericks adapt swiftly to changing market conditions. They're agile, responsive, and open to pivoting when necessary. Their flexibility allows them to stay ahead of the curve.

Agility

Mavericks take calculated risks. They're not afraid to explore uncharted territory, whether it's launching a new product, adopting cutting-edge technology or entering new markets.

Risk-Taking

Maverick organizations empower their employees. They encourage autonomy, trust their teams, and create an environment where diverse ideas flourish. Engaged employees drive innovation.

Employee Engagement

Becoming the Maverick of Diagnostics<br>

"Boule is a global provider of advanced hematology equipment that contributes to safer diagnostics worldwide.
Being part of a mission that helps people every day is something I truly care about."

Maria Cansund Lundin

"What makes Boule a good place to work is that there are opportunities for development."

Isac Warnebrant

"We're like a tight-knit group, often hanging out over coffee during breaks and chatting together."

Arta Gashi

"Regular team meetings and clear task delegation keep us coordinated and productive."

Jesper Åhlén

"The environment at Boule makes me feel safe and cared for."

Senada Halilovic

"Boule facilitates professional growth through a range of learning opportunities, enabling us to continuously develop."

Aumed Hana

What do our people say about working at Boule?

Gallery

<html><head></head><body><div>We’re looking for a<strong> Regulatory Affairs professional</strong> who enjoys working close to the business, not just documenting it.</div>
<div>At Boule, QA/RA plays an important role in supporting the organization, helping balance compliance with speed, enabling informed decisions, and contributing to sustainable growth.</div>
<div>This role combines Regulatory Affairs with a strong QA perspective, contributing to an efficient and risk-based QMS and enabling sound decision-making across the organisation.</div>
<div>You’ll be expected to translate requirements into workable solutions, navigate complexity, and help the organisation move forward in a compliant and practical way.</div>
<div><br><strong>What you’ll do</strong></div>
<ul>
<li>Drive regulatory activities across markets for our instruments and reagents (human and veterinary)</li>
<li>Contribute to regulatory strategies and product lifecycle management</li>
<li>Support and provide documentation for global registrations via distributors and partners</li>
<li>Work closely with R&amp;D, Operations, and Commercial teams</li>
<li>Interface with Notified Bodies and regulatory authorities regarding submissions, substantial system changes, and new product developments</li>
<li>Review design dossiers, technical documentation, and labeling to support regulatory approvals</li>
<li>
<div>Stay informed on regulatory updates and changes, ensuring proactive and compliant implementation</div>
</li>
<li>Translate regulatory requirements into clear, practical, and business-relevant guidance</li>
<li>Contribute to an efficient and risk-based QMS, with focus on usability and value</li>
<li>Challenge and simplify processes where possible</li>
<li>Apply pragmatic, risk-based thinking in decision-making, ensuring compliance while supporting efficient and timely execution</li>
</ul>
<div><strong>We think you bring</strong></div>
<ul>
<li>minimum 3+ years experience in Regulatory Affairs within MedTech/IVD</li>
<li>Understanding of both devices and consumables/reagents</li>
<li>Familiarity with relevant technical and product safety areas (e.g. electrical safety, EMC, laser safety (IEC 60825), and chemical regulations such as CLP/GHS)</li>
<li>Understanding of software-related regulatory requirements, including awareness of software lifecycle, validation, and cybersecurity considerations in a medical device context</li>
<li>Experience working in a QMS (ISO 13485)</li>
<li>Experience working with international distributors and global markets</li>
<li>Experience with veterinary products is an advantage</li>
<li>Fluent in English and Swedish</li>
</ul>
<div><strong>Most importantly</strong><br>You are pragmatic and structured, with the ability to apply risk-based thinking in complex situations.</div>
<div>You work closely with the business and can translate regulatory requirements into practical solutions, ensuring compliance while supporting progress and efficiency.</div>
<div>&nbsp;<br><strong>What we offer</strong><br>At Boule, you will be part of an engaged team with short decision-making paths and plenty of room for your own initiatives.</div>
<div>In this role, you will work with established products in a global context, with a central responsibility in navigating complex international flows and collaborating closely with colleagues and distributors worldwide. You will also have good opportunities to influence and improve our processes.</div>
<div>We value a safe and sustainable work environment with strong employment conditions and therefore offer the possibility of hybrid work. Boule is covered by the Swedish collective bargaining agreements (Teknikavtalen). For salaried employees, this includes agreements with Unionen, Sveriges Ingenjörer, and Ledarna, and for blue-collar employees, IF Metall.</div>
<div>The position is located in Spånga, just outside Stockholm.</div>
<div>&nbsp;<br><strong>Recruitment process</strong><br>If your profile matches the role, we will invite you to an initial interview with HR. This is followed by more in-depth meetings with relevant department stakeholders, in a process where your potential role is central.</div>
<div>&nbsp;<br><strong>Application</strong><br>Welcome to submit your application no later than June 30. Selection is ongoing, so please don’t wait to apply.</div>
<div>If you have any questions, you are warmly welcome to contact the HR department at: hr@boule.se</div>
<div>Welcome to become part of Boule — we look forward to your application!</div>
<div>&nbsp;<br><strong>About the company</strong><br>Boule Diagnostics AB is a global diagnostics company that develops, manufactures, and sells systems and consumables for blood cell counting (hematology). The company primarily serves small and medium-sized hospitals, clinics, and laboratories, as well as other diagnostics companies within both human and veterinary hematology.</div>
<div>Operations are conducted through subsidiaries in Sweden, the USA, Mexico, and other locations. Sales are global, primarily via distributors, supported by Boule’s own local sales and service personnel.</div>
<div>Since 2011, Boule Diagnostics has been listed on Nasdaq Stockholm. As a leading player in decentralized hematology diagnostics, Boule is known for high quality, user-friendly products, and a strong international presence.</div>
<div>In 2025, Boule Diagnostics was included in Allbright’s Green List and recognized as one of Sweden’s most gender-equal companies — an award that reflects our continued focus on an inclusive and balanced workplace.</div></body></html>