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QA/RA Manager – Medical Devices
You’re the key to bringing our medical device to CE

As Quality Assurance & Regulatory Affairs Manager at Haermonics, you’ll play a critical role in the development and certification of medical device products. You understand the worlds of engineers, clinicians, and management; more importantly, you have the ability to inspire them to work with a quality mindset. You know what it takes to create a Technical File for submission to authorities and understand how this impacts our development process. We’re a startup, so you’re going to have a big impact and be directly involved in development, production and approval of our innovative products. In short, we’re looking for someone with the heart of a changemaker, the mind of a strategist and the hands of an engineer.

Your responsibilities:

In general, you’re the Keeper of all things Quality Assurance and System / Regulatory Affairs. More specifically you are expected to:

  • Play a vital role in developing new products
  • Are expert in the field of medical device regulations and product certification
  • Also play an important QA role in product development, working collaboratively with our strategic suppliers of system and disposables
  • Be responsible for the guarantee of safety of our products and ensuring working adherence to the Quality Management System
  • Coordinate regularly with our suppliers on QA/RA matters
  • Arrange the technical file for the certification of our products

What you bring to the team:

  • Minimum of 3 years of experience in Quality Assurance and Regulatory Affairs with regard to medical devices, with Class II/III devices, preferably in surgical applications, critical care, or patient monitoring
  • Knowledge of medical legislation and regulations, such as the new EU MDR, the FDA regulations, and applicable ISO/IEC standards
  • Affinity with working in a can-do startup setting (lean and compliant)
  • Experience in Quality Management
  • Setting up and management of an ISO 13485:2016 compliant QMS
  • Electronic document management
  • 21 CR 830, ISO 14971 / IEC 62304 / IEC 62366 / ISO 10079 / IEC 60601 / …..
  • Experience with QMS certification process via a Notified Body
  • Alignment with QMS’s of suppliers (system, disposables)
  • Quality Assurance – Records / Technical File
  • Supporting the team with creation of all required Technical File documents according the QMS and templates
  • Supporting Clinical Studies in collection of data and required evidence
  • Regulatory context:
  • Class III device (EU), DeNovo class II device with special controls (FDA)

What we offer:

Our goal is to save 10,000 lives by 2030. So we’re looking to build a dedicated team that we can count on, so that others can count on us. Besides a driven purpose, joining the Haermonics team will give you:

  • A competitive salary.
  • 28 Days of leave and the possibility to purchase up to 10 extra days off annually
  • Colleagues who are the best and brightest in their field
  • A personal development budget, free training and coaching (after all, remaining “the best and brightest” requires ongoing dedication)
  • A young, dynamic, international, high-tech startup environment, where you will collaborate daily with top-level medical device suppliers
  • Direct access to clinical practices and colleagues in leading academic centers
  • A share package (because our success is your success and we’re looking for long-term committers)

About Haermonics

When it comes to solving important, real-life medical problems, the Haermonics team brings discipline, creativity and extensive testing to each and every elegant solution. Currently conducting a clinical trial in 4 clinics of our innovative post cardiac surgery flushing technique, we’re in the final product development stages, aiming to go to market early 2024.

We are curious by nature. “Is there a better way?” is our daily reflection. Undaunted by the complicated, we understand that in every tangle of complexity, there lies an elegant solution. We strip a problem down to its essence. We simplify to clarify.  Because simplicity inspires action.  Above all, we believe in what we do. Unbound by convention, we are the change we want to see in the world. Viva la evolution.