Senior Regulatory Affairs Program Lead

Ethicon Inc., a member of Johnson & Johnson’s Family of Companies, is recruiting for a Senior Regulatory Affairs Program Lead for Wound Closure and Healing with a preferred location of Raritan, New Jersey; however, remote work options may be considered for the right candidate. The Ethicon business offers a broad range of products, platforms, and technologies—including sutures, surgical staplers, advanced energy, robotic surgery, clip appliers, trocars and synthetic mesh devices—that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity. The Ethicon business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. was founded more than 80 years ago, as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of open surgery. The Senior Regulatory Affairs Program Lead has end to end responsibility for the life cycle maintenance and new product development launches within the Wound Closure and Healing portfolio. The Senior Regulatory Affairs Program Lead provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches. Under little to no supervision, the individual leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers. He/she guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials. The Senior RA Program Lead helps to define data and information needed for regulatory approvals in conjunction with cross-functional product development teams. The role assists in the identification and development of best practices for Regulatory Affairs processes. In this role, you will: Provide input and guidance during New Product Development and Lifecycle Management projects, including regulatory strategy and supporting evidence including clinical data Ensure compliance with regulatory agency regulations and interpretations Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines Prepare responses to regulatory agencies' questions and other correspondence to resolve post-submission queries ensuring timely approvals Communicate, negotiate, and maintain rapport with the FDA and Notified Body reviewers to identify pre-submission requirements and ensure submission strategy alignment as needed Provide solutions to extreme complex problems in which data analysis requires an evaluation of intangible variables Lead the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers Guide conformance with applicable regulations in product development, support of claims and label content Define data and information needed for regulatory approvals Collaborate in the development and approval of labeling, after evaluating conformance to regulations Provide Regulatory Affairs support during internal and external audits Plans schedules for regulatory deliverables on a project and monitors project through completion Assists in the development of best practices for Regulatory Affairs processes and systems Represents Regulatory Affairs and provide regulatory advice on cross-functional project teams Partners with other functions to define and obtain data to assist with regulatory submissions The following competencies apply to this role: Leverages a deep scientific and technical understanding of regulated products under scope of responsibility to provide strategic guidance and support for product development and life-cycle management of products (for example, represents Regulatory in the product recall and recall communication process). Integrates and executes results-oriented Regulatory Affairs strategies that are aligned with organizational objectives. Takes accountability for the achievement of business goals and objectives. Clearly defines and prioritizes decision criteria and considers benefits, risks, and Credo of each alternative before making decisions. Considers all of the available facts when situations are ambiguous in order to make the best possible decision (for example, when regulations are unclear). Consistently manages large, complex, and/or ambiguous information from multiple sources and makes timely and effective decisions for the execution of project objectives. Connect by encouraging and supporting internal collaboration across levels, creating effective solutions. Builds and leverages internal and external networks with colleagues, cross-functional partners, and industry contacts to identify opportunities and open communication channels Shape by challenging the status quo and adapting to change, taking advantage of opportunities to have a positive impact. Engages with local and/or regional regulatory agencies, industry groups, standards committees, political/government agencies, in order to influence external stakeholders and promote Regulatory perspectives Lead by leveraging diverse perspectives, backgrounds and talent to generate effective ideas or solutions Deliver by acting with speed, flexibility , accountability and appropriately managing priorities to deliver results for on-time clearances Qualifications Bachelor degree from accredited college or university in science, biomedical engineering, medical / scientific writing, public health administration and 6 years of regulatory affairs or related/equivalent experience OR an advanced degree (M.S., M.E., Ph.D. or M.D.) and a minimum of 3 years of related experience is required. Experience in healthcare products product industry including submissions is required. Experience with clinical development, strongly preferred Previous medical device submission experience for medium and high risk devices is preferred. Demonstrated track record of leadership success is strongly preferred Experience leading multi-functional teams, preferred Previous experience with combination products is preferred. RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society, desirable Experience working and negotiating with regulatory bodies is desirable. The position is preferred to be located in Raritan, NJ or can be remote for the right candidate with up to 20% travel is required. At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. The base pay range for this position is $101K to midpoint $142K. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. 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 Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below. Information on benefits can be viewed by following this link: https://www.careers.jnj.com/employee-benefits Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability. Primary Location United States--- Other Locations United States-New Jersey-Raritan Organization Ethicon Inc. (6045) Job Function Regulatory Affairs Requisition ID 2206005699W