Regulatory Affairs Lead for EMEA Region
il y a 1 semaine
We are seeking a highly experienced Regulatory Affairs professional to join our team as a Senior Regulatory Affairs Manager EMEA. This is a fantastic opportunity to lead a dedicated team and ensure compliance across innovative products throughout their lifecycle.
As a key member of our team, you will be responsible for all regulatory activities in the EMEA region, including managing requests from legal entities and affiliated companies to support product design, change management, and post-market activities.
You will participate in regional and global projects, collaborating with internal stakeholders and global RA teams to ensure that EMEA regulatory requirements are known and considered in projects.
Key responsibilities include managing all regulatory activities related to the import and distribution of products within the EU, supervising regulatory activities related to the design, manufacture, and distribution of custom-made Class I products, and centralizing, organizing, and processing regulatory requests as needed.
As a business partner, you will serve as the primary contact for all regulatory requests related to European operations activities and manage European regulatory surveillance in accordance with internal processes.
Requirements include a degree qualification with a minimum of 7 years' experience in Regulatory Affairs positions in the medical device industry, excellent knowledge of the regulatory and normative framework of Medical devices in Europe, and fluency in French and English.
Why join us? We offer a supportive work environment with flex office options, opportunities for growth and development, leadership opportunities, and a positive and dynamic environment.
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