Regulatory Specialist
Boule Medical AB / Biomedicinjobb / Stockholm
2026-05-29
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hela Sverige Visa alla jobb hos Boule Medical AB i Stockholm 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.seWelcome 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.
Så ansöker du Sista dag att ansöka är 2026-06-30
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Boule Medical AB (org.nr 556128-6542)
Fagerstagatan 7 (
visa karta)
163 53 SPÅNGA
Jobbnummer 9935449