Senior Compliance Engineer

mementor DE GmbH

Not specified (assumed flexible/hybrid based on company culture)
Samd regulatory compliance expertise
Iso 13485 eu mdr audit experience
Risk management plan creation
mementor DE GmbH is seeking a Senior Compliance Engineer to ensure that their software as a medical device (SaMD) and health software applications meet regulatory standards. The role involves collaborating with software engineering teams, conducting audits, and managing risk assessments in a supportive and innovative environment

Job Summary

  • The role involves acting as the primary Subject Matter Expert for internal and external audits on assigned medical device products.
  • Candidates will shape software product design and development processes to ensure compliance with rigorous safety and security standards.
  • The company offers a supportive environment focused on people development and the opportunity to build meaningful health technology solutions.

Matching Summary

Match Score: 85

mementor DE GmbH is seeking a Senior Compliance Engineer to ensure that their software as a medical device (SaMD) and health software applications meet regulatory standards. The role involves collaborating with software engineering teams, conducting audits, and managing risk assessments in a supportive and innovative environment.

Skills & Requirements

Must-have

  • SaMD regulatory compliance expertise
  • ISO 13485 EU MDR audit experience
  • Risk management plan creation
  • Software development lifecycle knowledge
  • Third-party library security evaluation

Nice-to-have

  • Clinical pathway understanding
  • Privacy law familiarity GDPR HIPAA
  • Innovative team culture participation
  • Global collaboration experience

Key Requirements

  • BS/MS in engineering or scientific discipline
  • 4-5 years medical device industry experience
  • 3-5 years experience with ISO 13485 EU MDR audits
  • Proficiency in technical analysis and reporting

Work Rights

Not specified

Tailored Resume

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