Are you looking for a role where you can truly make a difference? Do you thrive in a dynamic, collaborative environment where your ideas are valued? If so, you might be our next Excellence Maker!  

We are looking for a Quality & Regulatory Affairs Expert to join our growing Aurevia team. We are seeking an experienced medical device quality and regulatory consultant with strong technical competence, together with ISO 13485 and FDA quality systems expertise. In this role, you will support clients in bringing medical devices into EU (MDR/IVDR) and US (FDA) markets, build lean yet compliant processes, and coach product and quality teams from concept to market and across the full lifecycle. 

In this role, you will collaborate closely with cross-functional teams, including quality assurance, regulatory affairs, and R&D, to uphold stringent regulatory standards within various health tech projects.  

The position is full-time and permanent, and remote or hybrid work is possible (within Finland). Aurevia has office locations in Helsinki, Tampere, and Turku.  

Responsibilities 

• Planning, creating, updating, and providing guidance on medical device regulatory compliance and on technical documentation. 

• Building, maintaining, and developing customer Quality Management Systems compliant to MDR 2017/745, IVDR 2017/746, ISO 13485 and/or FDA QMSR. 

• Supporting customer quality and regulatory teams to prepare documentation for regulatory submissions. 

• Communicating with regulatory authorities and Notified Bodies.  

• Conducting gap analyses of technical documentation, planning and reporting. 

• Performing audits and providing training. 

• External roles in clients’ quality and regulatory functions. 

 
Requirements for the role 

• 5+ years’ experience in medical device QA/RA related tasks. 

• Solid technical competence in at least one of the following competence areas: IVD devices, medical devices, medical software or AI (in medtech domain). 

• Experience in practical implementation of ISO 13485, MDR/IVDR and preferably in ISO 14971 and IEC 62304.  

• University or higher education degree (MSc. or PhD.). 

• Strong project management and communication skills. 

• Ability to manage multiple projects simultaneously and work independently. 

• Proactive and service-oriented way of working. 

• Fluent English, both written and spoken. Additionally Finnish proficiency is preferred. 

Preferred competence 

Experience in one or several of these areas is considered beneficial: 

• Software development

• Medical device cybersecurity

• Organization security 

• Medical electrical devices (experience in IEC 60601 or IEC 61010 standard family) 

• US FDA regulations, pre-submissions, and submissions 

• Global registrations 

• IVD performance evaluations

• Combination products 

• UDI and labeling 

What We Offer:   

At Aurevia, we are the excellence makers - a team of experienced experts in healthcare and health-tech standards and quality. Together, we drive healthcare, pharmaceutical, and medical technology development with a future-focused approach aligned with client needs. Guided by our commitment to care, we deliver quality to the industry and pave the way for safer, more effective patient care worldwide.   

Join Aurevia - a fast-growing, modern company! Our growth and dynamic environment provide an excellent platform for professional development and innovation. Our employees value our open, collaborative culture, where expertise is recognized, and career growth is supported. As one team member put it: “I wouldn’t want to be anywhere else, being a part of this international growth is incredibly interesting and rewarding.”  

Our employees enjoy a high degree of autonomy and the opportunity to shape the direction of their work. We support work-life balance through flexible working arrangements. We offer a compensation package that reflects your skills and experience, and we are open to discuss salary expectations — please include your desired salary in your application. Additionally, we provide a comprehensive benefits program.  

Ready to Apply?   

If this sounds like the perfect opportunity for you, we’d love to hear from you! Please submit your application, including your CV, salary request and cover letter, through the application form by April 30th. We review applications and conduct interviews during the application period and will fill the position as soon as we find a suitable candidate. If you have any questions about the position, feel free to reach out to our QARA Operations Managers: 

• Mika Siitonen; phone inquiries during following times: April 10th between 1-2 pm or April 15th between 2-3 pm, +358 50 381 2757 or

• Terhi Heikkinen; email inquiries until April 15th terhi.heikkinen@aurevia.com (Applications will not be accepted by email) 

We look forward to receiving your application. Join our team and make an impact!