<ul> <li>Job title Regulatory Affairs Specialist (EES) - MedTech Surgery </li><li>Function Regulatory Affairs Group </li><li>Sub function Regulatory Affairs </li><li>Category Analyst, Regulatory Affairs (P4 - E24) </li><li>Location Cincinnati / Raritan / United States of America </li><li>Date posted May 12 2025 </li><li>Requisition number R-013232 </li><li>Work pattern Hybrid Work </li></ul> <p>This job posting is anticipated to close on May 26 2025. We may however extend this time period, in which case the posting will remain available on www.careers.jnj.com to accept additional applications.</p> <p>Description</p> <p>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 https://www.jnj.com</p> <p>Job Function:</p> <p>Regulatory Affairs Group</p> <p>Job Sub Function:</p> <p>Regulatory Affairs</p> <p>Job Category:</p> <p>Professional</p> <p>All Job Posting Locations:</p> <p>Cincinnati, Ohio, United States of America, Raritan, New Jersey, United States of America</p> <p>Job Description:</p> <p>We are searching for the best talent for a Regulatory Affairs Specialist to be located in Cincinnati, OH or Raritan, NJ. This role will work a Flex/Hybrid schedule with 3 days per week in office. There is NO remote option.</p> <p>Purpose: The Regulatory Affairs Specialist provides regulatory guidance to project teams in strategic planning and related submissions to support Ethicon Endo Surgery (EES) products. Under minimal supervision, the individual develops and executes regulatory strategy for significant change supplements and 510(k) registrations to support continued commercialization of products in key countries. The Specialist helps to define data and information needed for regulatory actions in conjunction with cross-functional teams. He/she guides conformance with applicable regulations through the development of best practices for Regulatory Affairs processes, procedures and systems.</p> <p>You will be responsible for:</p> <ul> <li>Ensures compliance with regulatory agency regulations and interpretations. </li><li>Prepares responses to regulatory agencies' questions and other correspondence. </li><li>Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines. </li><li>Provides solutions to a variety of problems of moderate scope and complexity. </li><li>Researches and collects data; and responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to associates and affiliates. </li><li>Advises on regulatory labeling requirements specifications for modified products, and reviews product labeling to ensure compliance. </li><li>Provides regulatory guidance to project teams and responds to product information requests. </li><li>Provide Regulatory Affairs support during internal and external audits. </li><li>Assists in the development of best practices for Regulatory Affairs processes. </li><li>Represents Regulatory Affairs on cross-functional project teams. </li><li>Responsible for communicating business related issues or opportunities to next management level. </li><li>Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. </li><li>Performs other duties assigned as needed. </li></ul> <p>Qualifications / Requirements:</p> <ul> <li>Minimum of a Bachelor's Degree is required, Advanced Degree strongly preferred. Desired fields of study in Physical Sciences, Biomedical Engineering, Medical / Scientific writing, Public Health Administration or similar. </li><li>Minimum of 3+ years of Regulatory Affairs or related/equivalent experience within a highly regulated industry is required; 2+ with Advanced Degree. </li><li>Experience with healthcare products (Consumer and/or Pharmaceutical and/or Medical Device) industry and regulations is strongly preferred. </li><li>Knowledge of US and OUS health products regulations is preferred. </li><li>Previous medical device submission experience is highly desired. </li><li>Ability to work both independently and in a team environment to problem solve and recognize and find solutions for gaps in processes is desirable. </li><li>Leverages scientific and technical understanding of regulated products within scope of responsibility to provide regulatory input to product lifecycle management and evaluate regulatory impact on products (for example, provides regulatory assessments for product recall strategies). </li><li>Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives. </li><li>Consults with others to understand the benefits, risks, and Credo-based impact associated with decision alternatives before making decisions. </li><li>Provides support to complex projects and makes timely and effective decisions based on available information to execute project deliverables. Makes decisions with guidance in ambiguous or unclear situations. </li><li>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 </li><li>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. </li><li>Lead by leveraging diverse perspectives, backgrounds and talent to generate effective ideas or solutions </li><li>Deliver by acting with speed, flexibility, accountability and appropriately managing priorities to deliver results for on-time clearances </li></ul> <p>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.</p> <p>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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.</p> <p>#LI-Hybrid</p> <p>#LI-BF1</p> <p>The anticipated base pay range for this position is :</p> <p>The anticipated base pay range for this position is $74,000 to $119,600.</p> <p>Additional Description for Pay Transparency:</p> <p>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. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits</p> <p>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.</p> <p>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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.</p> <p>#LI-Hybrid</p> <p>#LI-BF1</p>