Senior Director Global Regulatory Affairs for Advanced Surgery Medical Devices and Biologics

23 hours ago

Deerfield Beach, Florida, United States Baxter Full time
About the Role

Baxter's Advanced Surgery business is a $1 billion division within our Medical Products and Therapies Global Business Unit (GBU). As the Senior Director Regulatory Affairs, Advanced Surgery, you will be responsible for leading the global regulatory strategy and performance of the Regulatory Affairs (RA) function within the division.

Key Responsibilities
  • Develop and implement global regulatory strategies and proactively influence and shape the regulatory environment in support of business goals and strategies.
  • Interface with management levels on significant matters, often requiring coordination of activity across multiple functions and divisions.
  • Manage all regulatory activities associated with Advanced Surgery, including development, implementation, and management of global regulatory strategies.
  • Participate in the Advanced Surgery Leadership Team as a key business partner to provide regulatory strategy and guidance for new product development (NPD) and business growth and expansion strategies.
  • Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with members of Regulatory and other cross-functional teams.
  • Effectively communicate regulatory strategies and project developments to project teams, colleagues, line management, and key stakeholders.
  • Negotiate and interact with regulatory authorities, including oversight, planning, and leadership of meetings.
  • Maintain awareness of the global regulatory environment and assess the impact of changes on business and product development programs.
  • Oversee development and negotiation of overall plans regarding safety, efficacy, and quality to assure viability for global registrations.
  • Ensure that regulatory submissions meet appropriate standards and content requirements.
  • Identify potential strategic/tactical decisions that will affect the company's success for long-term range planning (LRP).
  • Develop and manage budget for the business unit RA group.
  • Recruit, develop, and lead a team of regulatory professionals in development of strategic plans and regulatory submissions.
  • Oversee team management and development.
  • Engage in policy development within the organization and with external groups.
  • Guide proactive relationships with regulatory authorities to facilitate interactions for critical issues.
  • Influence the direction of the regulatory function and ensure development of competencies and capabilities for current and future goals.
About the Team

The Senior Director Regulatory Affairs, Advanced Surgery reports to the Vice President, Global Regulatory Affairs. As the Senior Director, you will have a geographically dispersed team of approximately 25. You will collaborate and interface with other GBU and regional RA, marketing, NPD R&D, sustaining engineering, business operations, service, sales, corporate engineering, Advanced Surgery cross-functional Leadership Team, etc.

About the Location

The role is located at our global corporate headquarters in the greater Chicago, IL area northern suburb of Deerfield. Consideration will also be given to remote work from a US location.

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