Head, Regulatory Affairs, Joints, Digital and Power Tools

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Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

People Leader

All Job Posting Locations:

Palm Beach Gardens, Florida, United States of America, Raynham, Massachusetts, United States of America, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America

Job Description:

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.

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

The ability to actively develop talent and culture to achieve results is required.

Experience working with professional and trade associations is a plus.

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. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers and internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

$196,000.00 - $342,700.00

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company’s long-term incentive program.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year

Holiday pay, including Floating Holidays –13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave – 80 hours in a 52-week rolling period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits