Healthcare Quality & Regulatory Projects Lead

Linxens Group; Paris; Sur place; EUR 70 000 - 95 000; Plein temps

Résumé du poste

Linxens Group is seeking a Healthcare Site Quality & Project Leader with a strong RA QA background in the medical device industry. You will coordinate healthcare projects, assure compliance with ISO 13485 and other regulations, and implement quality controls.

Candidates should have an academic degree in engineering or life sciences, with a minimum of 7 years experience in quality assurance. Linxens offers a multicultural environment and opportunities for career growth.

Qualifications

• Minimum 7 years experience in quality assurance and/or regulatory affairs in the medical device business.
• Minimum 5 years of people leadership experience.

Responsabilités

• Coordinate the integration of healthcare projects.
• Ensure compliance with regulatory requirements.
• Conduct internal audits and contribute to external audit preparation.

Connaissances

RA QA background in medical device industry

ISO13485, MDR, FDA 21 CFR part 820/QSR/QMSR

Lean Six Sigma Green Belt or Black Belt

Strong oral and written communication skills in English

Formation

Academic degree in engineering or life sciences

Description du poste

Linxens Group is seeking a Healthcare Site Quality & Project Leader with a strong RA QA background in the medical device industry. You will coordinate healthcare projects, assure compliance with ISO 13485 and other regulations, and implement quality controls.

Candidates should have an academic degree in engineering or life sciences, with a minimum of 7 years experience in quality assurance. Linxens offers a multicultural environment and opportunities for career growth.