Osimis jobs

Quality & regulatory affairs manager

Osimis is a company based in Liège, Belgium. We help medical institutions to grow with our imaging solutions.

We are a team of 12 people and we have high ambitions. As a Quality & Regulatory Affairs Manager you will be the guardian of the quality and regulatory compliance in charge of managing the corporate quality management system and the product application lifecycle management system.  

You’ll interact with the company C-level, the product owner, the development team as well as the data privacy officer. You'll be responsible for providing leadership for the development and maintenance of Osimis quality system for medical devices, surveillance and gap analysis of external and internal standards/regulations as well as auditing internal departments and external suppliers. Enhancing patient outcomes is at the center of everything that we do, and Quality & Regulatory compliance are critical aspects of ensuring that we deliver on our commitment to patients and healthcare professionals.

Your responsibilities

Reporting to the CEO, you work in close cooperation with all departments in the company and with our suppliers. Your main responsibilities are:

  • Guarantee the quality policy of the company. Ensure that this policy is understood, implemented and maintained at all levels of the organization while complying with the appropriate external regulatory requirements (including but not limited to ISO/IEC, EU Medical Device Regulations, GDPR, FDA and individual country requirements)
  • Assess the regulatory requirements for new products, manage regulatory submissions and obtain approvals in a timely manner
  • Prepare and maintain Technical Files and Design Dossiers in support of CE Marking of existing and new Medical Devices
  • Perform audits and provide audit support both internally and with suppliers
  • Negotiate the best path forward based on available time, resources and the voice of the customer
  • Report to management on the implementation and effectiveness of the quality management system and identify needs for improvement

Quality manager

‍Requirements

  • Bachelor or Master degree in the life science or engineering area
  • Minimum of 5 years’ experience in regulated environments/regulatory agency interactions required
  • Knowledge and experience of global medical devices and product regulations (e.g. EU Medical Device Regulations, ISO 13485, ISO 27001, FDA, IEC62304…) are strong assets
  • Experience leading and facilitating audits
  • Results and customer oriented, rigorous, autonomous and flexible
  • Analytical, organized, team player, open-minded with a start-up mindset
  • Strong oral and written communication
  • Great organizational skills & a ‘getting things done’ attitude
  • English + French speaking (written + oral). The command of any other language is an asset
  • Self-learner

Pluses

  • You have a background in medical software or medical imaging

Offer, Benefits & Perks

  • Half-time position in a motivated, lively start-up environment and contribute to making better medical decisions that enhance patients' outcome
  • International exposure, with significant learning and evolution opportunities
  • Space for you to add your knowledge, skills and expertise to the team, and the company as a whole, without being rigid about the way things need to be done
  • An attractive salary package
  • Super flexible working hours (we are a partially remote team)
  • A true "startup" environment with a lot of possibilities to express yourself

Our values

  • Customers first
  • Open science is the future of healthcare
  • Think outside the (healthcare) box
  • Make mistakes
  • Be lazy (in the productive sense)
  • Only "no ego" doers
  • The devil is in the detail
  • KISS
  • Freedom & responsibility
  • Have fun & be happy

Location

Minimum 1 day at our awesome offices in Liège + Remote