Regulatory Affairs Specialist

Job description

Develop, implement, and lead the regulatory regional strategy, in alignment with company goals, for new and sustaining ZOLL Resuscitation products and features. - Develop and successfully implement regional regulatory strategies for new and sustaining products/features that result in device approval. - Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. - Provide strategic regional regulatory perspective during the development, review, and approval of internal and external documentation to support the development and commercialization of assigned product(s). - Work with RA regional and product teams to ensure that regulatory requirements are appropriately considered and accounted for in programs and projects. - Author and prepare submittals of IDEs, 510(k), PMAs, Technical Files or Design Dossiers, and other pertinent regional device applications. - Work with management on risk assessment and regulatory compliance. - Support Cross-Functional NPI Project Teams and provide regulatory guidance. - Maintain current knowledge...