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Corporate Regulatory Affairs & QA Manager

Michael Page
Contratto a tempo indeterminato
    Our client is one of the world's leading manufacturer of medical diagnostic Essential Responsibilities include, but are not limited to::Provide group-wide coordination of the activities necessary to define and deploy the plan and strategy for premarket regulatory submissions to obtain and maintain regulatory approval of products in all the Business Regions and meet the Group business objectives. Manage a team of RA specialists (both direct and functional reports) as they execute new product registrations in all markets as planned: research, analyze, integrate and organize background information from diverse sources for regulatory submissions Assess project plans and timelines and ensure all projects are appropriately prioritized and key goals are met on time. Interface with multi-functional groups to provide regulatory guidance regarding the management of issues throughout the product life cycle, including labeling requirements, registration requirements and timing, and expectations of the regulatory bodies. Monitor and communicate new regulatory requirements to the affected functional groups. Develop strategies to ensure proactive planning to be compliant with new requirements and new regulations for product registration and set priorities for those activities. Develop and grow the regulatory department in keeping with the needs of the company, and coach and mentor department staff. Supports regulatory inspections as required Master's degree, preferably in a scientific discipline A minimum of 10 years of experience working in Quality and Regulatory Affairs within a global medical device industry, of which 5 years in a senior leadership role. A strong knowledge and practical experience in worldwide regulations for Medical Devices, successful submission and approval, particularly as they relate to EU, U.S.A., Canada, China, and Brazil requirements. Proven leadership in formulating and implementing global strategies to ensure compliance with worldwide regulations to maximize product market access. Ability to communicate effectively in English (both written and oral) Strong competence in collaboration and teamwork, communications influence, strategic thinking, planning and organizing, driving results and problem solving Effective time management, ability to prioritize and manage multiple projects simultaneously
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