Regulatory Affairs Expert

2 days ago

Helsinki, Uusimaa, Finland Aurevia Oy Full time

Are you our next Quality Maker?

We are looking for an experienced medical device quality and regulatory expert to join Aurevia in a permanent, full-time position. Join our team of dedicated medical device professionals, providing high-quality services to economic operators across the industry. Our services address both quality and regulatory needs throughout the entire lifecycle of medical devices and quality management systems.

Why join us?

At Aurevia, we offer diverse and impactful assignments, ranging from large-scale projects to smaller tasks, such as bringing a new medical device to the selected markets, establishing a quality management system, creating a regulatory plan, or performing an internal audit. Our satisfied customer base includes large established global players, start-up companies, and everything in between.

We offer a front row view to the medtech industry within Nordic's leading expert organization in quality and regulatory affairs. The extensive experience and expertise of our team members ensure a strong local support network and a platform for discussions in an ever-changing and developing operating environment. You will have the opportunity to collaborate with friendly and professional colleagues, providing high-quality services in our field.

Your responsibilities and tasks include, for example:

  • Building, maintaining, and developing the Quality Management System
  • Planning, creating, updating, and providing guidance on regulatory compliance and Technical Documentation
  • Conducting gap analyses of technical documentation, planning and reporting for biological evaluation, usability engineering, electrical safety documentation, software lifecycle management processes, clinical/performance evaluation, and registrations
  • Performing audits and providing training
  • External roles in client's quality and regulatory functions

We hope you have:

  • Strong expertise (4+ years) in the medical device industry
  • Experience in quality & regulatory affairs (e.g. ISO 13485, ISO 14971, MDR, IVDR)
  • Specific experience in software and IEC 62304 or in vitro diagnostics (IVD) products is an advantage
  • Experience in US FDA regulations is an advantage
  • University or higher education degree (MSc. or PhD.)
  • Excellent project management and communication skills
  • A proactive, service-oriented mindset
  • Ability to manage multiple projects simultaneously and work independently
  • Fluent proficiency in English (spoken and written), additionally Finnish proficiency is preferred

What we offer:

Join Aurevia - a rapidly growing and modern company We support the balance between work and leisure through flexible work arrangements (including remote work and flexible working hours). We offer a salary commensurate with your expertise and work experience. We want to discuss the salary with you, so please provide an estimate of your salary expectations on the application form. In addition, we provide a comprehensive benefits package (including cultural and sports benefits through Smartum, health insurance, and a phone benefit).

The workplace is located according to your preference, for example, in our offices in Helsinki, Tampere, or Turku, and there's a possibility for remote work. We work in close collaboration with our Swedish QARA teams in Stockholm and Lund. At Aurevia, you become part of a collaborative and top-notch expert team

Additional information:

For more information about the position, please contact Mika or Terhi:

Mika Siitonen, Head of Digital Health, QARA Team Lead
mika.siitonen@aurevia.com
+358 9 8566 8264
NOTE Phone inquiries only during the following hours: March 11th (3-4 pm.) & March 17th (1-3 pm.)

Terhi Heikkinen, QARA Team Lead, MD & IVD
terhi.heikkinen@aurevia.com
+358 9 8566 8250
NOTE Phone inquiries only during the following hours: March 18th (3-4 pm.) & March 27th (3-4 pm.)

We conduct interviews during the application period and fill the positions as soon as we find suitable candidates. If you are interested, please submit your CV, cover letter, and salary expectations by no later than April 4th, 2025.

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