Compliance Manager

Functie

As Compliance Manager you will be responsible for maintaining and improving the current quality, security & privacy management system for the activities of Extra Horizon.

Your mission

• Ensure that the Compliance Management System requirements are effectively established and in accordance with applicable medical device regulations, standards and guidelines
• Conduct internal audits and provide guidance regarding best practices and continuous improvement.
• Support core quality systems including root cause analysis, CAPA, non conformance, chance control, and risk management, as well as control of documentation and records.
• Coordinate external audits from notified bodies and customers. Follow up on any actions resulting from these audits.
• Maintain expert current knowledge of European and foreign regulations, legislations, best practices and guidelines related to QA/RA, monitor changes to applicable laws and regulations, identify impact to the business, and in collaboration with other stakeholders, develop response strategies.
• Manage key quality and regulatory affairs initiatives to drive continuous improvement.

Your profile

• In depth understanding of a quality/security/privacy Management System, and requirements for ISO 13485, MDR and other relevant regulations
• Thorough understanding of quality assurance concepts and practices
• Ability to interpret and apply regulations and compliance concepts
• Detail oriented, you understand the importance of getting every detail right
• A Master's or a Bachelor's degree in engineering, technical or science field
• A minimum of 3 years of work experience in quality, security or privacy management.
• Excellent communication skills, written and verbal
• Excellent written and spoken English, additional languages are considered a plus
• Strong organisational and presentation skills

• Het plan, de fases en de acties van kwaliteitsopvolging ontwikkelen en uitvoeren
• Domein: Kwaliteitsgarantie
• Technische ondersteuning en advies geven aan diensten en klanten (ontwerp, uitwerking, ...)
• Kwaliteitsprocedures uitwerken en aanpassen en de correcte toepassing controleren
• Domein: Continue verbetering
• Kwaliteitsgegevens opvolgen en analyseren
  Veranderingen en verbeteringen bepalen
• Documentatiemateriaal voorzien, beheren en actueel houden
• Domein: Kwaliteitscontrole
• De personeelsleden bewustmaken van en opleiding geven over de benadering van kwaliteit
• Domein: Kwaliteitsmanagementsysteem
• Gevallen van non-conformiteit analyseren
  Corrigerende acties bepalen en aanbevelen

Aanbod

Why you should apply

• You will join a wonderful welcoming team of highly-skilled people in an exciting, challenging and innovative start-up, with plenty of opportunities to grow.
  
• We offer flextime and a high degree of self-management, with remote-first as an option and offices at the Corda Campus in Hasselt.
  
• A very open and honest company culture where you can have true impact on people’s lives.
  
• A full-time job, attractive salary and numerous benefits.

Come do the best work of your life here at Extra Horizon!

Solliciteren

Sharina Leppens
+32 473 30 37 97
office@extrahorizon.com