Director, Regulatory Affairs

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: We are searching for the best talent for a Director, Regulatory Affairs to join our Orthopaedics team located in Palm Beach Gardens, FL, West Chester, PA, Warsaw, IN or Raynham, MA. Purpose: The Director, Regulatory Affairs is responsible for setting regulatory strategy, and in partnership with cross-functional teams, driving excellence in product innovation, launch and portfolio management. This position is also responsible for providing direction and leadership to the Regulatory Staff in the development and implementation of global regulatory strategies and processes to assure timely commercialization of products in key markets in compliance with current and appropriate worldwide regulatory expectations. Responsibilitiesinclude: In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: Leads and manages activities concerned with the submission and approval products to government regulatory agencies. Develops world-wide regulatory strategies to ensure rapid and timely approval of devices and continued regulatory support of marketed devices and other products. Administers Regulatory Affairs operations including setting strategic direction and communicates business goals and objectives. Oversees the preparation and maintenance of regulatory submissions and files including but not limited to 510(k)'s, IDE/IDE Supplements, PMA/PMA Supplements, HDE/HDE Supplements, Annual Reports, Design Dossiers/Change Notifications, and Technical Files for a diverse range of orthopaedic products, including Class III devices. Defines the strategic regulatory direction for pipeline development and global launch excellence for a significant dedicated R&D budget Partners with R&D, Quality, Supply Chain, Global Strategic Marketing leaders and other cross-functional leaders to develop and implement strategy for pipeline development and global launch excellence Exercise highly complex level of independent judgment and execution directly impacting the operational results of the business unit; manages, oversees and balances resource allocation across critical projects; and is responsible for regulatory aspects of product lifecycle management Lead and develop Regulatory staff to become future leaders Partners with Policy to monitor the regulatory environment globally and provide assessments of the impact of new and changing regulations on the company's research and development programs to management Establish and ensure deployment of learning initiatives and training of cross functional partners on current and emerging regulatory and related requirements. Responsible for ensuring aligned and coordinated contact and communication with global and regional/local regulatory agencies Ensures that company policies, procedures and practices are in compliance with appropriate regulatory requirements Assures timely regulatory clearances for key product launches in all key markets and assesses the current state of the department (organizational structure, competencies and skills) and implements a strategic vision and tactical plans consistent with the organizational and RA strategic objectives. Inspires, motivates and communicates vision to regulatory associates, peers. Identify and assess external innovation opportunities connected to the area of responsibility– both screening & technical due diligence (or designate team member) Represent Johnson & Johnson’s strategic focus area in various internal and external forums and strategy/interactions Functional, Leadership, and Technical Competencies: Connect by cultivating external relationships with regulators in key markets (in partnership with Regions, Policy and EU Strategy leads) and internally collaborating with the R&D, Med Affairs, Clinical Affairs, GSM and other partners. Shape by anticipating and influencing regulatory changes in key markets to maximize patient access to innovative technologies Lead by acquiring and developing a diverse team of talented regulatory professionals and transparently communicating in a constructive manner Deliver by mobilizing and inspiring an accountable team to deliver results for on-time clearances with a global and enterprise-wide mind-set and balance with strategic and short-term goals Strategic thinking and ability to partner and Influence key stakeholders at senior levels. Leverages expert scientific and technical understanding of medical devices and/ or biologics to serve as an expert resource and strategic partner for development and planning throughout the product lifecycle in applicable markets (for example, partnering with business partners to proactively address safety issues). Builds, sustains, and rewards a culture of innovative thinking, informed risk taking, intellectual curiosity, and the continual learning of scientific, technological, and Regulatory developments. Leverages expertise to educate and coach others on the development and execution of business plans and Regulatory Affairs strategies with a focus on innovative results. Advises and challenges others, including cross functional business partners, to ensure the best business-level best decisions are consistently made within the organization and based on the Credo. Makes and stands behind complex and difficult decisions in ambiguous situations with a large potential impact on the organization. Qualifications & Experience Minimum of a Bachelors’ degree within a technical related discipline is required. M.S., M.E., PhD or MD is highly preferred. Minimum 10 years relevant / regulated industry experience is required. Previous experience with medical devices and digital surgical robotics is strongly preferred. Senior leadership experience is required, including line management of multiple levels of reporting. Demonstrated track record of developing and executing global regulatory strategies that align with business deliverables is required. About Orthopaedics Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their journey to wellness. Learn more at Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. 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 & 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, please contact us via or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Business Writing, Collaboration, Compliance Risk, Continuous Improvement, Developing Others, Fact-Based Decision Making, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Legal Support, Operations Management, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Strategic Thinking The anticipated base pay range for this position is : $164,000.00 - $282,900.00 Additional Description for Pay Transparency: 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: - #J-18808-Ljbffr Regulatory Jobs