Compliance Manager

• 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.
  

• 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

• 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!

Extra Horizon is a young, dynamic & fast paced MedTech company based in Hasselt, Belgium. As a spin-off from FibriCheck, and backed by experienced Venture Capital, Extra Horizon has developed a game-changing cloud platform for cloud connected medical devices.

Extra Horizon is now commercialised as an off-the-shelf platform solution for the fast evolving and growing digital health space. Specifically in the area of remote patient monitoring, where digitalisation and the shift to home-care is taking place, there is a huge potential and opportunity to be captured. Our solution can provide a compliant cloud infrastructure to the diagnostics, R&D, biotech, pharma and MedTech industries to enable their entry into the digitalisation, but also speed up their time to market.

The key expertise of Extra Horizon is the design and development of software solutions that resolve regulatory, GDPR/HIPAA, and cybersecurity challenges for our customers.