Scope: Director of regulatory affairs position that has been opened to further accompany the growth of the company in this sector.
Although our client is a historically pharma-oriented manufacturer, they have in recent years expanded their activities in the Medical Aesthetics area, with products currently on the market in Dermal and Hyaluronic acid fillers, and potential to develop and increase the product range through a strong RD push, as well as targeted acquisitions.
Your role as a regulatory director will be to oversee the push to market for new product developments as well as lifecycle management of currently marketed products.
You will be currently handling 2 direct reports, with a strong growth pipeline projected due to a strong product development push and a target to market an extra 10 to 15 products in the near future.
As a Regulatory Affairs director, you will be central to the growth of the organization and will have with this role a fantastic opportunity to step up from your current managerial role to Senior Management responsibilities!Responsibilities:Responsibility for planning, directing, coordinating, and controlling the regulatory affairs activities related to the Energy Based Devices product portfolio.Strategic and logistical regulatory planning with the Global Head of Regulatory Affairs and development of global regulatory strategies for existing products and upcoming pipeline.Providing leadership to cross-functional teams during new product development.Managing technical guidance and training to cross-functional teams and other Regulatory Affairs members including training on procedures, FDA, MDR guidance documents, and international regulation.Managing activities aimed at obtaining/maintaining the medical CE marking and marketing licenses in global markets, with an overview of registration and internationalization processes.Managing a multicultural and multi-location team.Participation in Post Market Surveillance Team to ensure compliance with product post-marketing approval requirements.Overview of device labeling for compliance on a global scale.About You:University degree preferably in Life Sciences, Engineering, or other technical discipline.Minimum 6+ years of experience in a managerial role as Regulatory Affairs Manager/Director in the Medical Devices industry.Vast knowledge of U.S. Food and Drug Administration (FDA) regulatory pathways and MDR EU regulation.Mandatory strong knowledge of ISO 13485, IEC 60601, ISO 14971, IEC 62304, ISO 10993.Excellent computer skills (including but not limited to Windows and MS Office).
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