Associate Director, Regulatory Affairs-Front Line Care

This role will be responsible for global strategic planning of the portfolio within a business unit including development, implementation and management of plans and standards. Lead, mentor, and develops others in service of Baxter's objectives in alignment with FLC’s Cardiology and Respiratory Health segments. Responsible for all aspects of regulatory strategy for the respiratory health and diagnostic cardiology product segments. Provide quarterly regulatory intelligence impact assessments for SNG, STP and MKE. Oversee Notified Body consolidation activities for cardiology and respiratory health. Mentor staff for 510(k) submissions, EU MDR submissions, MDD certificate extensions, Life 2000 EUA transition plan and multiple RH and Cardiology NPD and sustaining projects. Provide regulatory strategy for the site consolidation and site transfers. Develop and implement regulatory strategy aligned with business strategy. Identify & prioritize key areas of risk and probability of occurrence as well as ensure implementation of mitigation plans and follow ups. Participate in identification of risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans. Initiate and maintain appropriate communication within the RA function and represent Regulatory Affairs with business units and other functions. Act as primary contact for meetings with the regulatory authorities including the planning and leadership. Implement policies to ensure ongoing compliance with regulatory requirements. May manage regulatory budget at project level. Independently lead global regulatory strategy development, planning, and implementation for multiple complex programs and platforms. May represent Baxter interests in industry and working groups. Guide and influence technical groups in areas of product development. Assess impact of new regulations and implement appropriate changes as well as lead development of company policy and positions on draft regulation and guidance. Responsible for negotiating and decision making with regulators and stakeholders with complex and high-risk projects. May provide direct supervision of individuals including mentoring, performance management and staffing decisions.