Lead Compliance & Quality Officer

Remote
Full Time
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Lead Compliance & Quality Officer

About Awell

Awell is a digital health company enabling care teams to design, build, execute and optimize care pathways. Our mission is to help healthcare providers and patients answer the most difficult question in healthcare: “What’s next?”.

We are a team of 15 people, some of us are based in Brussels, others across Europe. We are  backed by LocalGlobe, Moonfire and others.

We are looking for open-minded people who are committed to continuously improving themselves and the world around them. Our culture is one of responsibility, high productivity and genuine feedback. 

As a Lead Compliance & Quality Officer at Awell, you’ll be responsible for driving our compliance & quality approach for existing and new markets. You will provide a framework and structure that supports regulatory compliance across the company as it grows in size and complexity. You will be  working closely with our software engineers, sales and delivery teams and focus on the development and maintenance of registration for relevant medical device regulations as well as quality assessment.

This is a full-time position, either based in Brussels or remote.

Your responsibilities

This is both strategic and hands-on role, where you'll be responsible for:

  • Managing continued implementation and adherence to compliance & quality standards across Awell.
  • Developing and maintaining registration, conformity assessment, post-market, and vigilance processes to meet relevant medical device regulations, including MDR, across multiple continents (priority markets Europe, UK and US)
  • Ensuring that our offering enables our clients (digital health companies) to comply with relevant regulatory requirements
  • Collaborating with the Product Management team to ensure that our offering complies with relevant regulatory requirements
  • Supporting preparation and reviewing technical documentation
  • Building awareness and proficiency around compliance and quality in the wider team
  • Appling GDPR, HIPPA and IT security processes and principles

The person we are looking for

  • Is a subject matter expert and spearheads compliance and quality initiatives in their company.
  • Has significant experience in regulatory affairs & quality assurance
  • Has a bachelor (minimum) or master degree and experience in the medical sector (medical devices) and/or legal/regulatory sector.
  • Knowledge of Quality Management (ISO 13485) and Medical Device Regulation (MDD/MDR) are required. Knowledge of ISO 27001, GDPR and HIPPA are considered a plus.
  • Applies regulatory guidelines and regulation in practice.
  • Works independently and keeps track of your planning & deadlines in line with team and company milestones.
  • Works precisely and administration/reporting is complete and tidy.
  • Thrives in a quickly changing environment that challenges your multitasking skills

Benefits

  • 👩‍⚕️ Full-time employment
  • 💰 Competitive salary
  • 🏢 On-site, hybrid or remote (we're based in Brussels 🧇 🍫)
  • 📈 Stock options
  • 💻 Hardware of choice
  • ⏱️ Flexible work hours
  • 🛫 Flexible vacation policy
  • 📚 No limit books on amazon
  • 🇧🇪 Regular tickets to Brussels if you're remote (depends on your location)

How to apply

Send your application to careers@awellhealth.com

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