Regulatory Affairs Specialist I - Spine

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, with smarter and less invasive treatments and personalized solutions. Through our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver breakthroughs of tomorrow and profoundly impact health for humanity. Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Raynham, Massachusetts, United States of America Job Description 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. We are recruiting for a Regulatory Affairs Analyst – Spine, located on-site in Raynham, MA. This is a J&J Flex position with minimum three days of on‑site work. There is no full‑time remote option. Key Responsibilities Provides regulatory guidance to product development teams in defining regulatory strategies, pre‑marketing, and related submissions to support optimal timelines for new/modified product launches in the global market. Executes on the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers, including, but not limited to 510(k) submissions, pre‑submissions, HDEs, change notifications, technical documents, and correspondence with health authorities. Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials. Defines data and information needed for regulatory marketing authorizations. Develops labeling specifications and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations. Provides Regulatory Affairs support during internal and external audits. Plans schedules for delivery of supporting documentation required for regulatory submissions on a project and monitors the project through completion. Assists in the development of improved and efficient process practices for Regulatory Affairs processes. Represents Regulatory Affairs on cross‑functional project teams, guiding and supporting product development teams on both US and international issues. Partners with other functions to define and generate data to assist with regulatory submissions. Reviews and provides regulatory authorization for changes to products, processes, and quality system procedures. Responds to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approvals in other countries, and provides routine regulatory information to associates and affiliates. Qualifications Minimum of a bachelor’s degree required, advanced degree strongly preferred. Desired fields of study include science, engineering (e.g., biomedical, electrical, software, mechanical), business, legal, or similar. Experience in a highly regulated industry preferred, preferably with medical devices. Relevant internship experience may be considered. Demonstrated intellectual capacity to identify, read, understand, and address global medical device regulations. Experience in the preparation and submission of US regulatory filings (e.g., 510(k), PMA) as well as European technical files and design dossiers. Knowledge of US and European regulatory processes. Must have excellent written, verbal communication, and presentation skills. Other This position will be located in Raynham, MA, and may require up to 10% domestic and international travel. Required Skills 510(k) Submission Analytical Analysis Regulatory Operations Preferred Skills 510(k) Submission Analytical Analysis Regulatory Operations Pay Transparency The anticipated base pay range for this position is: $64,000.00 – $102,350.00. Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)) and in the long‑term incentive program. Benefits Vacation – 120 hours per calendar year Sick time – 40 hours per calendar year (48 hours in Colorado; 56 hours in Washington) 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 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 period Volunteer leave – 32 hours per calendar year Military spouse time‑off – 80 hours per calendar year EEO and Disability Accommodation We ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. If you would like to request accommodation, please contact us. 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, protected veteran status, or disability. For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit For additional general information on Company benefits, please visit #J-18808-Ljbffr Johnson & Johnson MedTech