Senior Vice President, Quality & Regulatory Affairs

Boule Diagnostics | Stockholm

Senior Vice President, Quality & Regulatory Affairs

Boule Diagnostics AB operates in the field of laboratory medicine, with a particular focus on hematology systems for automated blood cell count for both the human and veterinary markets. The company is an international group with 98 percent export, and with sales in over 100 countries. Subsidiaries and sales offices are located in Sweden, the USA, China, Mexico, Russia, and India. Boule Diagnostics AB is listed on NASDAQ Stockholm. The company provides its own development, production and sales, and is located in Spånga in Stockholm. The Boule group has about 215 employees. 

Boule is looking for a new Senior Vice President, Quality & Regulatory Affairs

The role has global responsibilities and will be part of the Executive Management Team. You will have a high impact on the strategy and future growth of Boule.

You are an experienced and strong international leader with excellent professional skills within the quality and regulatory areas (MDR/IVDR). Furthermore, you are an excellent people manager with a high drive and strong cooperation and stakeholder management skills.  

About the position

The Senior Vice President, Quality & Regulatory Affairs (Sr VP QA&RA), will report to the CEO.

You will be leading an organization of about 15 FTE within regulatory affairs, quality and compliance.  The teams are based in USA, Sweden and Russia.

The Sr VP QA&RA will provide strategy and direction to ensure all Quality and Regulatory Affairs systems are established, implemented and maintained in accordance with applicable standards for the company and worldwide regulatory requirements.  

The role is also responsible for ensuring that the business meets or exceeds the expectations of customers and other stakeholders in these areas. The position will oversee the global business done with distributors in more than 100 countries.  

Who are we looking for?

Your background:

·       Bachelor’s or Master’s degree in Engineering or Life Science

·       Demonstrated success in effectively leading and developing a quality and regulatory organization

·       Maintain the Quality Risk Management system to assure that risks are adequately controlled as per current requirements.

·       Excellent working knowledge of regulatory requirements and submissions globally (10+ years’ experience of European IVDD and US FDA requirements and submissions for IVD products) 

·       Working across functions in an international production company

·       Previous experience of participating in leadership teams

·       High proficiency in English in speech and writing


Personal Qualifications 

·       A natural, confident, and strong leader who sets ambitious goals and consistently reaches them (continuous improvement mindset) 

·       Excellent people manager with ability to coach, lead and develop your team

·       Assertive, poised, and professional personality with ability to build bridges, influence and negotiate

·       Results driven with strategic and holistic mindset

·       Hands-on and works in a systematic, methodical and well-structured manner with ability to prioritize   


Travelling will be required. The position is preferably based in Spånga, Stockholm, Sweden, but also location in Plantation, Florida, USA may be considered.

Does this sound like a job for you? Please read more about the company at . 

How to apply

If this sounds interesting, please apply directly or contact us for more info.

Catharina Bergold   tel +46(70) 217 9879

Ann-Katrin Broman , tel +46(70) 755 5094

Torbjörn Ströberg , tel +46(70) 377 8774

We look forward to your application!