Quality & Regulatory Affairs Expert
About this role
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