Axepta SA EU Regulatory Affairs Manager Medical Devices Envie

My client is a global healthcare company continuously growing with offices all around the world.

Due to continuous growth, my client is looking for EU Regulatory Affairs Manager to lead a Regulatory Affairs team dedicated to the preparation, maintenance of technical files as well as of innovations and is a key member of the EU RA Healthcare Leadership Team. The person will also be in charge of regulatory affairs dossiers and registration strategy group and is responsible for executing regulatory submission and compliance strategies to enable business growth.

The position can be based in one of their offices located near Marseille or near Lille area with flexibility of home working.

Responsibilities:

· Develop and execute global regulatory submission strategies for new or existing products to enable product registrations and distribution to markets.

· Develop a strategy to ensure and continuously improve the effectiveness of the organisation including execution of processes, development, and monitoring of relevant metrics.

· Assess and promote compliance with existing laws and regulations pertaining to medical devices.

· Partner closely with counterparts in Operations, Quality, Supply Chain, Research & Development, Marketing, and Legal to ensure effective execution of the regulatory strategy.

· Support interactions with external agencies such as Notified Bodies, Competent Authorities, and OEM customers on audits.

· Collaborate with designated PPRC to ensure compliance to applicable medical devices product regulations.

· Support improvement projects including enhancements to processes, procedures, infrastructure, and digital tools to ensure compliance to applicable regulatory requirements and enable business growth.

· Part of due diligence activities on acquisition targets.

· Lead and develop a team of Regulatory Affairs

Your profil:

· Master degree in a technical field, including engineering, scientific disciplines (ex: chemistry, biology, etc), medicine, and pharmacy, regulatory affairs.

· 8 to 10 years of medical device experience in a manager role implementing requirements such as EU MDR, ISO 13485, ISO 14971 in a complex multi-site business.

· Experience leading remediation programs, resolution of product quality and regulatory compliance matters.

· Experience in product registrations and submission strategies in the EU and global markets.

· Demonstrated grasp of business and regulatory processes

· Excellent written and verbal communication skills in English