Senior EMEA Post-Market Surveillance Specialist

Integra-Lifesciences; Saint-Priest; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

Integra Lifesciences in France is seeking a Regulatory Vigilance Specialist to support post‑market compliance and medical device vigilance, assessing patient and compliance risk and coordinating with regulatory authorities.

The role requires a Bachelor’s degree in science, 3–5 years’ experience in the medical device sector, knowledge of ISO13485/MDR, and strong writing, project management, and cross‑functional collaboration skills.

Qualifications

• Bachelor’s degree in science or related field.
• 3–5 years in medical device/pharma with quality engineering/regulatory focus.
• Knowledge of ISO13485, MDR, and adverse event reporting considered a plus.
• Proficient with Excel/SharePoint and web navigation.

Responsabilités

• Evaluate complaints and determine reportability under European regulation.
• Complete decision trees with cross‑department input.
• Prepare Manufacture Incident Reports for vigilance and submit to authorities.
• Prepare authorities inquiries with site support and timely submission.
• Support European Medical Specialists in vigilance decisions or reporting.
• Participate in regulatory audits/inspections as required.
• Represent Integra in PMS working groups.
• Transfer information to stakeholders and update procedures as needed.
• Stay updated on new regulations, standards, and guidance documents.

Connaissances

Regulatory affairs concepts

Medical device knowledge

Quality systems

Risk assessment

Regulatory writing

Formation

Bachelor's degree in science

Outils

Excel

SharePoint

Description du poste

Integra Lifesciences in France is seeking a Regulatory Vigilance Specialist to support post‑market compliance and medical device vigilance, assessing patient and compliance risk and coordinating with regulatory authorities.

The role requires a Bachelor’s degree in science, 3–5 years’ experience in the medical device sector, knowledge of ISO13485/MDR, and strong writing, project management, and cross‑functional collaboration skills.