Functie

YOUR MISSION

As QA/RA Manager, your primary mission will be to support XEOS in quality and regulatory affairs matters and become our in-house expert in navigating regulatory complexities and in maintaining our quality management system.
By ensuring compliance and strategic direction, you will play an important role in advancing our mission of bringing groundbreaking medical technologies to the operation room.

YOUR ROLE
The main purpose.

In this role, you will oversee quality assurance and regulatory affairs activities within our QARA department, staying ahead of regulatory changes, managing registrations, engaging with authorities, implementing ISO standards, and overseeing our quality management system.
You will provide strategic leadership to our team, ensuring compliance with relevant regulations and standards while driving continuous improvement initiatives.

YOUR RESPONSIBILITIES
The things you do.

• Stay up to date with regulatory changes and requirements ( Europe and USA)
• Maintain and improve our quality management system ( ISO 13485 )
• Manage registrations and compliance with regulatory agencies
• Engage with authorities and coordinate audits as needed (internal/external audits)
• Review promotional material and clinical documentation
• Design and implement ISO standards for data protection and information security (ISO 27001)
• Provide project management and strategic guidance to the QARA team
• Oversee product change management and risk management processes
• Manage compliance of all employees and co-workers to ensure correct implementation (and follow up of all procedures) of the quality management system
• Identify relevant quality-related training needs and organize trainings

Jouw profiel

YOUR QUALIFICATIONS
The things you know.

Knowledge/Experience

• Master of Science, Law or Engineering or comparable through experience
• Minimum of 5 years of experience in regulatory affairs in the MedTech industry
• Knowledge and certifications in ISO 13485 and 27001
• Must be able to understand, interpret and implement quality standards and regulatory guidelines
• Demonstrated interest in complex legislative topics and life sciences (e.g. medical, data, radiation...)
• Auditing experience, ability to lead internal audits
• Fluent in English, written and spoken

Soft skills

• Able to identify problematic situations, to communicate appropriately, to initiate problem solving processes and to propose remedial actions
• We value an entrepreneurial mindset and a strong sense of ownership. These qualities not only align with our start-up culture but also empower you to excel in your mission
• Have a strong attention to detail
• Out-of-the-box thinker with a passion for learning
• Strong communication skills, both verbal and written
• Ability to handle multiple topics and stakeholders simultaneously
• Comfortable in uncertain, rapidly changing environments and help out where needed

NICE TO HAVE’S
The things we love.

• Knowledge of Dutch and additional (West-European) languages preferred
• Certification in ISO or Data Protection Officer (DPO) is a plus
• Experience in implementing ISO13485 and ISO27001
• Eagerness to continuously enhance your expertise and knowledge to stay up to date
• Inner drive to actively seek ways to continuously improve processes

• De activiteiten van een team coördineren
  Een organisatie leiden
• De personeelsleden bewustmaken van en opleiding geven over de benadering van kwaliteit
• Het plan, de fases en de acties van kwaliteitsopvolging ontwikkelen en uitvoeren
• Kwaliteitsprocedures uitwerken en aanpassen en de correcte toepassing controleren
• Documentatiemateriaal voorzien, beheren en actueel houden
• Kwaliteitsgegevens opvolgen en analyseren
  Veranderingen en verbeteringen bepalen
• Domein: Kwaliteitsmanagementsysteem
• Een kwaliteitsaudit, een leveranciersaudit, een milieuaudit, ... uitvoeren
• Een project leiden
• Gevallen van non-conformiteit analyseren
  Corrigerende acties bepalen en aanbevelen
• Technische ondersteuning en advies geven aan diensten en klanten (ontwerp, uitwerking, ...)

Aanbod

WHAT WE OFFER
The things that matter.

• Join a motivated and entrepreneurial team with a mission to provide surgeons and clinicians with the best tools to improve patient outcomes, making your work feel truly meaningful
• Gain a wide range of skills and experiences thanks to the steep learning curve of a highly innovative MedTech start-up
• Receive a high degree of ownership and responsibility with a major impact on the growth phase of a promising start-up. Your ideas and efforts can shape the company's trajectory
• Experience a positive company culture with a tight-knit, collaborative culture. You'll work closely with experienced & bright colleagues from different backgrounds and functions, promoting teamwork and relationship-building

On top of that, we will reward you with a competitive remuneration , fully adapted to your needs, including meal vouchers, group insurance, hospitalization insurance, training possibilities, and more.

If you're ready to revolutionize healthcare and grow with a forward-thinking company, we invite you to join us on this remarkable journey.

MEET US
Sounds like chemistry? Let’s find out!

Send your story and your resume to and you might just join our amazing team and help us shape the future of healthcare.

Solliciteren

Stéphanie Droesbeke
+3293971810
stephanie.droesbeke@xeos.care