Pre-market - Qara

Dedalus

Bordeaux, France
**
Iso 13485 knowledge required
Medical device regulation mdr expertise
Risk management principles application
** Dedalus is seeking a Pre Market Quality and Regulatory Specialist to join their healthcare technology team in Bordeaux, France. The role involves ensuring quality and regulatory compliance in product development, with a focus on medical devices and software, while contributing to Dedalus's mission of improving healthcare. **

Job Summary

  • The role ensures ongoing Quality and Regulatory compliance as an embedded member of development project core teams.
  • Candidates must be subject matter experts in regulatory affairs with in-depth knowledge of ISO 13485, ISO 14971, and the new Medical Device Regulation.
  • Dedalus fosters a culture where employees are encouraged to learn and innovate to help clinicians deliver better care.

Matching Summary

Match Score: 75

** Dedalus is seeking a Pre Market Quality and Regulatory Specialist to join their healthcare technology team in Bordeaux, France. The role involves ensuring quality and regulatory compliance in product development, with a focus on medical devices and software, while contributing to Dedalus's mission of improving healthcare. **

Skills & Requirements

Must-have

  • ISO 13485 knowledge required
  • Medical Device Regulation MDR expertise
  • Risk management principles application
  • Design control regulations proficiency
  • English and French language skills

Nice-to-have

  • GDPR awareness preferred
  • FDA or ANVISA regulation knowledge
  • Microsoft Office advanced skills
  • QMS tools experience
  • Independent work towards deadlines

Key Requirements

  • Expert PC operation skills
  • Professional level English and French
  • Subject matter expert in regulatory affairs

Work Rights

Not specified

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