Regulatory Affairs Program Lead – Medical Devices

NEMERA; Lyon; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

NEMERA in Lyon is seeking a Regulatory Affairs Project Manager (F/M/X) responsible for leading regulatory design projects for drug delivery devices. You will interact with cross-functional teams to ensure compliance with regulatory requirements.

The ideal candidate has an engineering degree, at least 5 years of experience in the medical devices industry, and knowledge of regulatory standards. NEMERA values diversity and inclusion, providing an equitable work environment.

Qualifications

• At least 5 years professional experience.
• Background in the combination products or medical devices industry.
• Knowledge of eCTD Module 3 CMC, CE certification, Notified Body Opinion process.

Responsabilités

• Lead the regulatory design projects of drug delivery devices.
• Prepare and submit regulatory documents to authorities.
• Collaborate with development teams to ensure regulatory compliance.

Connaissances

Regulatory Affairs

Quality Management Systems

Interpersonal Skills

Analytical Skills

Formation

Engineering degree or equivalent

Outils

eCTD

ISO 13485

MDR 2017/745

Description du poste

NEMERA in Lyon is seeking a Regulatory Affairs Project Manager (F/M/X) responsible for leading regulatory design projects for drug delivery devices. You will interact with cross-functional teams to ensure compliance with regulatory requirements.

The ideal candidate has an engineering degree, at least 5 years of experience in the medical devices industry, and knowledge of regulatory standards. NEMERA values diversity and inclusion, providing an equitable work environment.