Regulatory Affairs Director
hace 2 semanas
**Scope**:
Director of regulatory affairs position that has been opened to further accompany the growth of the company on this sector. Although our client is a historically pharma oriented manufacturer, they have in the recent years expanded their activities in the Medical Aesthetics area, with products currently on market in the Dermal and Hyaluronic acid fillers, and potential to develop and increase the product range through a strong R&D push, aswell as targeted acquisitions. Your role as a regulatory director will be to overview the push to market on new product developments as well as lifecyle management on current marketed products. You will be currently handling 2 direct reports, with strong growth pipeline projected due to a strong product development push and 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 organisation, 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 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 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 labelling for compliance on 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).
Managed by Benjamin Violet
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