Head Regulatory Affairs Joints

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 role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

• USA
  - Requisition Number: R-093494
• Switzerland – Requisition Number: R-093902
• UK
  - Requisition Number: R-093934
• Ireland
  - Requisition Number: 093940

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 include:

• Serving as a key leader on Joints, Digital and Power tools Leadership Teams, as well as the DePuy Synthes Regulatory Affairs Leadership Team
• Developing and implementing a strategic vision and operational plans for the Regulatory Affairs team to support the Platforms' and Regulatory Affairs' strategic objectives
• Ensuring 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
• Leading the development and execution of strategies supporting the most expeditious regulatory pathways for introduction of VELYS technologies in targeted markets
• Developing and implementing the overall regulatory strategy for digital technologies, including robotics, sensors, wearables, and apps, within the Joint Reconstruction Platforms' overall business strategy
• Assessing external innovation opportunities – both screening and technical due diligence.
• Partnering with R&D and other Platform leaders to develop and implement strategies for pipeline development
• Exercising a highly sophisticated level of independent judgment and execution directly impacting the Platforms' operational results
• Supervising the regulatory environment globally and providing assessments to Platform management of the impact of new and changing regulations on the Platforms
• Building an organization with the right talent and capabilities to implement regulatory support
• Encouraging, empowering and communicating vision to regulatory associates and peers
• Ensuring aligned and coordinated contact and communication with global and regional/local regulatory agencies
• Leading, coordinating and balancing resource allocation across multiple critical projects
• Ensuring that company policies, procedures and practices are in compliance with appropriate regulatory requirements
• Providing progress updates to key business team members on a regular and as-needed basis
• Representing DePuy Synthes strategies in various internal and external forums
• Establishing and ensuring deployment of learning initiatives and training of Platform personnel on current and emerging regulatory and related requirements.

Qualifications/requirements include:

• Minimum of a B.A./B.S. is required.
• Minimum of 10 years relevant, medical devices regulatory…