Senior Regulatory Affairs Specialist

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. Job Function Regulatory Affairs Group Job Sub Function Regulatory Affairs Job Category Professional All Job Posting Locations Diegem, Flemish Brabant, Belgium; Duelmen, Germany; Hamburg, Germany; Issy-les-Moulineaux, France; Lisbon, Portugal; Livingston, West Lothian, United Kingdom; Madrid, Spain; Warsaw, Masovian, Poland; Westport, Mayo, Ireland; Wokingham, Berkshire, United Kingdom Job Description We are searching for the best talent for a Senior Regulatory Affairs Specialist to join our Regulatory Affairs Global Strategy & Implementation team in Germany, UK, Spain, Belgium, Poland, Portugal or France. This is a full‑time, permanent position. Join our Surgery team to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world, helping treat conditions such as obesity, cardiovascular disease and cancer. Your contributions will help patients on their journey to wellness. The senior role supports regulatory excellence for Ethicon Endomechanical products, working closely with cross‑functional teams to implement new EU and key market regulations and develop regulatory strategies for new product developments. Key Responsibilities Ensure compliance with regulatory agency regulations and interpretations. Support the creation and implementation of regulatory strategies, including collaborating with cross‑functional teams (e.g., Business Unit Regulatory Affairs, R&D, Clinical, Quality, Regulatory Compliance and Marketing). Support the creation of Technical Documentation for MDR CE marking (Life Cycle Management and New Product Development projects). Support submissions to Notified Bodies and/or Competent Authorities (MDR, UKCA, initial applications, scope extensions, change notifications). Act as a strategic partner for Notified Body (NB). Develop knowledge of specific upcoming global key market regulations, communicate changes and support impact assessments to help Ethicon Business Units prepare for compliance in such markets. Perform the regulatory review of claims and marketing/promotional materials for copy approval purposes. Communicate business‑related issues or opportunities to next management level. Provide Regulatory Affairs support during internal and external audits. Ensure compliance with all Federal, State, Local and Company regulations, policies and procedures. Follow all Company guidelines related to Health, Safety and Environmental practices as applicable. Requirements A minimum of a bachelor’s degree in science, biomedical engineering, medical/scientific writing, law, public health administration or equivalent. A minimum of 3 to 5 years of Regulatory Affairs or related/equivalent experience. Experience with healthcare products (Consumer and/or Pharmaceutical and/or Medical Device) industry and regulations. Working knowledge of EU Medical Device regulatory matters including Medical Device Regulation (MDR). Analytical problem‑solving skills. Fluent in English, both written and spoken. Excellent communication and interpersonal skills. Ability to present to internal and external audiences. Ability to work both independently and in a team environment. Required Skills Regulatory Affairs Compliance Preferred Skills Analytical Reasoning Biomechanical Engineering Business Behavior Business Writing Communication Confidentiality Data Reporting Detail‑Oriented Law Legal Support Medicines and Device Development and Regulation Problem Solving Product Licensing Regulatory Affairs Management Regulatory Compliance Regulatory Development Regulatory Environment Risk Assessments Teamwork Johnson & Johnson is committed to providing an inclusive interview process that meets applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers. #J-18808-Ljbffr