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Job Title: Head, Regulatory Affairs, Joints, Digital and Power Tools Location: Warsaw, Indiana; Raynham, MA; Palm Beach Gardens, FL; West Chester, PA; Leeds, UK; Cork, Ireland; or Zuchwil, Switzerland 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. Please note that 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 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

01Serve as a key leader on Joints, Digital and Power tools Leadership Teams, as well as the DePuy Synthes Regulatory Affairs Leadership Team

02Develop and implement a strategic vision and operational plans for the Regulatory Affairs team to support the Platforms’ and Regulatory Affairs’ strategic objectives

03Assure 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

04Lead the development and execution of strategies supporting the most expeditious regulatory pathways for introduction of VELYS technologies in targeted markets

05Develop and implement the overall regulatory strategy for digital technologies, including robotics, sensors, wearables, and apps, within the Joint Reconstruction Platforms’ overall business strategy

06Assess external innovation opportunities – both screening and technical due diligence.

07Partner with R&D and other Platform leaders to develop and implement strategies for pipeline development

08Exercise highly sophisticated level of independent judgment and execution directly impacting the Platforms’ operational results

09Supervise the regulatory environment globally and provide assessments to Platform management of the impact of new and changing regulations on the Platforms

10Build an organization with the right talent and capabilities to implement regulatory support

11Encourage, empower and communicate vision to regulatory associates and peers

12Ensure aligned and coordinated contact and communication with global and regional/local regulatory agencies

13Lead, coordinate and balance resource allocation across multiple critical projects

14Ensure that company policies, procedures and practices are in compliance with appropriate regulatory requirements

15Provide progress updates to key business team members on a regular and as-needed basis

16Represent DePuy Synthes strategies in various internal and external forums

17Establish and ensure deployment of learning initiatives and training of Platform personnel on current and emerging regulatory and related requirements.

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 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.

Benefits

＋Johnson & Johnson is an Equal Opportunity Employer.

＋All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state, or local law.

＋We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

＋Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs.

Company

Johnson & Johnson / Janssen

Medical Devices

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. Learn more at jnj.com . 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.

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