Medical Device Compliance Specialist

7 days ago


Espoo, Uusimaa, Finland Surgify Medical Full time

Contribute to Patient Safety and Surgical Innovation

Surgify Medical is committed to developing innovative surgical solutions that improve patient safety and outcomes. We are seeking a skilled Regulatory Affairs Specialist to join our team and play a critical role in ensuring the regulatory compliance of our products.

The successful candidate will have a deep understanding of regulatory requirements, including those related to medical device compliance. They will be responsible for navigating complex regulatory landscapes, ensuring that our technology meets global standards, and collaborating closely with internal teams.

We value individuals who thrive in fast-paced environments, enjoy taking ownership, and have a strong attention to detail. This role offers an exciting opportunity to grow professionally, develop new skills, and make a meaningful contribution to the company's mission.

Key Responsibilities:

  1. Responsible for regulatory submissions and compliance processes
  2. Oversee registrations across multiple markets
  3. Support clinical documentation processes

What Makes You a Great Fit?

  • Relevant higher education degree
  • A couple of years of relevant work experience in regulatory affairs
  • Knowledge of regulatory processes, such as EU MDR and FDA 510(k) submissions
  • Full working proficiency in English


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