Head, Regulatory Affairs, Joints, Digital and Power Tools

Head, Regulatory Affairs, Joints, Digital and Power Tools

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative, and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services, and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. As the leading Orthopedic company, we are committed to a world where patients have access to care that is personalized and connected.

Together with customers, we are shaping the future of healthcare with technically and clinically sophisticated innovations that bring value for the global healthcare system.

This individual may be based in Warsaw, Indiana;
Raynham, MA;
Palm Beach Gardens, FL;
West Chester, PA;
Leeds, UK;
Cork, Ireland; or Zuchwil, Switzerland with a minimum of 25% travel to Warsaw, Indiana.

The Sr. Director, Regulatory Affairs is responsible for developing and implementing a strategic vision and operational plans for the Regulatory Affairs team to support the Platforms' and Regulatory Affairs' strategic objectives. This role will ensure timely regulatory clearances and registrations in support of key product launches required to support the Platforms' global business plans with a focus on strategic markets. This role will also be a key contributor to the Joints, Digital and Power tools Leadership Teams, as well as the DePuy Synthes Regulatory Affairs Leadership Team.

The role will report to the WW Vice President, Regulatory Affairs, Depuy Synthes.

Key Responsibilities:

• Serve as a key leader on Joints, Digital and Power tools Leadership Teams, as well as the DePuy Synthes Regulatory Affairs Leadership Team
• Develop and implement a strategic vision and operational plans for the Regulatory Affairs team to support the Platforms' and Regulatory Affairs' strategic objectives
• Assure timely regulatory clearances and registrations in support of key product launches required to support the Platforms' global business plans with a focus on strategic markets
• Lead the development and execution of strategies supporting the most expeditious regulatory pathways for introduction of VELYS technologies in targeted markets
• Develop and implement the overall regulatory strategy for digital technologies, including robotics, sensors, wearables, and apps, within the Joint Reconstruction Platforms' overall business strategy
• Assess external innovation opportunities – both screening and technical due diligence.
• Partner with R&D and other Platform leaders to develop and implement strategies for pipeline development
• Exercise highly sophisticated level of independent judgment and execution directly impacting the Platforms' operational results
• Supervise the regulatory environment globally and provide assessments to Platform management of the impact of new and changing regulations on the Platforms
• Build an organization with the right talent and capabilities to implement regulatory support
• Encourage, empower and communicate vision to regulatory associates and peers
• Ensure aligned and coordinated contact and communication with global and regional/local regulatory agencies
• Lead, coordinate and balance resource allocation across multiple critical projects
• Ensure that company policies, procedures and practices are in compliance with appropriate regulatory requirements
• Provide progress updates to key business team members on a regular and as-needed basis
• Represent DePuy Synthes strategies in various internal and external forums
• Establish and ensure deployment of learning initiatives and training of Platform personnel on current and emerging regulatory and related requirements.

Qualifications / Requirements:

• Minimum of a B.A./B.S. is required.
• Minimum of 10 years relevant, medical devices regulatory affairs experience is required. Previous experience with orthopedic devices is highly preferred.
• A minimum of 5 years of people management experience is required. Experience managing distributed, multi-national teams is preferred.
• Senior leadership experience is required, including line management of multiple…