Regulatory Specialist

We’re looking for a Regulatory Affairs professional who enjoys working close to the business, not just documenting it. 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. 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. You’ll be expected to translate requirements into workable solutions, navigate complexity, and help the organisation move forward in a compliant and practical way.

What you’ll do

Drive regulatory activities across markets for our instruments and reagents (human and veterinary)

Contribute to regulatory strategies and product lifecycle management

Support and provide documentation for global registrations via distributors and partners

Work closely with R&D, Operations, and Commercial teams

Interface with Notified Bodies and regulatory authorities regarding submissions, substantial system changes, and new product developments

Review design dossiers, technical documentation, and labeling to support regulatory approvals

Stay informed on regulatory updates and changes, ensuring proactive and compliant implementation

Translate regulatory requirements into clear, practical, and business-relevant guidance

Contribute to an efficient and risk-based QMS, with focus on usability and value

Challenge and simplify processes where possible

Apply pragmatic, risk-based thinking in decision-making, ensuring compliance while supporting efficient and timely execution

We think you bring

Minimum 3+ years experience in Regulatory Affairs within MedTech/IVD

Understanding of both devices and consumables/reagents

Familiarity with relevant technical and product safety areas (e.g. electrical safety, EMC, laser safety (IEC 60825), and chemical regulations such as CLP/GHS)

Understanding of software-related regulatory requirements, including awareness of software lifecycle, validation, and cybersecurity considerations in a medical device context

Experience working in a QMS (ISO 13485)

Experience working with international distributors and global markets

Experience with veterinary products is an advantage

Fluent in English and Swedish

Most importantly

You are pragmatic and structured, with the ability to apply risk-based thinking in complex situations. You work closely with the business and can translate regulatory requirements into practical solutions, ensuring compliance while supporting progress and efficiency.

What we offer

At Boule, you will be part of an engaged team with short decision-making paths and plenty of room for your own initiatives.

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.

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.

The position is located in Spånga, just outside Stockholm.

Recruitment process

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.

Application

Welcome to submit your application no later than June 30. Selection is ongoing, so please don’t wait to apply.

If you have any questions, you are warmly welcome to contact the HR department at: hr@boule.se

Welcome to become part of Boule — we look forward to your application!

About the company

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.

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.

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.

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.