Head Regulatory Affairs Joints

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Purpose: DePuy Synthes, a member of Johnson & Johnson family of companies, is currently recruiting for a Sr. Director, Regulatory Affairs, Joints, Digital and Power tools. 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:

Required:

• 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 levels of reporting.
• Proven success in partnering and influencing across a cross-functional environment is required.
• Proven track record of formulating and implementing global regulatory strategies in support of strategic business objectives is required.
• Previous experience with advanced digital technologies i.e. Data Science, Wearable Devices, Sensors, and/or Robotics is required.
• The ability to demonstrate relations with key constituents to deliver tangible results and clinical insights is required.
• Proven effective leadership and change management skills are required.
• The ability to actively develop talent and culture to achieve results is required.

Preferred:

• M.S., J.D., Ph.D. or M.D. is a plus.
• Professional demeanor and service orientation; standout colleague.
• Experience working with professional and trade associations is a plus.