Regulatory Affairs Manager

Job Summary: The RA manager leads a team to provide 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 minimal supervision, the individual leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers. The manager guides conformance with applicable regulations in product development, supports claims, and oversees content labeling and promotional materials. The RA manager serves as the company’s regulatory expert and is responsible for communications with FDA and international regulatory agencies. Responsibilities Provides independent regulatory guidance to product development teams in strategic planning, pre‑marketing, and related submissions to support optimal timelines for product launches. Manages the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers. Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials. Defines data and information needed for regulatory approvals. Develops labeling specifications and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations. Plans schedules for regulatory deliverables on a project and monitors project through completion. Leads in the development of best practices for Regulatory Affairs processes. Represents Regulatory Affairs on cross‑functional project teams. Partners with other functions to define and obtain data to assist with regulatory submissions. May work with International Affiliates directly. Provides Regulatory Affairs support during internal and external audits. Communicates business related issues or opportunities to next management level. Follows all Company guidelines related to Health, Safety and Environmental practices as applicable. For those who supervise or manage a staff, ensures subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition. Ensures personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. Performs other duties assigned as needed. Qualifications Required – Bachelor’s degree or equivalent and 6 years of related experience in the Medical Device industry or medical field. Preferred – Experience with power devices. Demonstrated knowledge of U.S. and EU Medical Device Regulations. Regulatory Affairs Certification (RAC) by the Regulatory Affairs Professional Society or an advanced degree in Regulatory Affairs. Ability to travel up to 10% domestically and internationally. Locations Palm Beach Gardens, Florida; Raynham, Massachusetts; West Chester, Pennsylvania; Synthes, Oberdorf; Zuchwil. EEO Statement 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. #J-18808-Ljbffr