Pre-market - Qara

Dedalus

Bordeaux, France
Not specified
Iso 13485
Iso 14971
Mdr and ivdr compliance
Dedalus is seeking a Pre Market Quality and Regulatory Specialist to join their team in Bordeaux, France, focused on ensuring compliance with quality and regulatory standards in healthcare technology. The role involves collaboration with project teams to manage regulatory submissions and uphold safety and efficacy standards for medical devices

Job Summary

  • Ensure ongoing Quality and Regulatory compliance as an embedded member of development project core teams.
  • Provide guidance and define regulatory plans and strategies, working with the project core team.
  • Facilitate regulatory compliance in design control processes to ensure that there are no compliance issues during regulatory inspections.

Matching Summary

Match Score: 85

Dedalus is seeking a Pre Market Quality and Regulatory Specialist to join their team in Bordeaux, France, focused on ensuring compliance with quality and regulatory standards in healthcare technology. The role involves collaboration with project teams to manage regulatory submissions and uphold safety and efficacy standards for medical devices.

Skills & Requirements

Must-have

  • ISO 13485
  • ISO 14971
  • MDR and IVDR compliance
  • Design control regulations
  • Medical device risk analysis
  • English and French professional level

Nice-to-have

  • ISO 27001
  • GDPR awareness
  • QMS tools knowledge
  • Microsoft Office advanced skills

Key Requirements

  • Subject matter expert in regulatory affairs
  • In-depth knowledge of healthcare quality standards
  • Ability to analyze and interpret regulations
  • Strong problem solving and project management skills
  • Excellent communication, research, organizational, and interpersonal skills
  • Expert PC operation skills
  • Professional level English and French

Work Rights

Not specified

Tailored Resume

Cover Letter