Senior Regulatory Affairs Specialist (Monarch) - MedTech Surgery

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. Job Function Regulatory Affairs Group | Regulatory Affairs | Professional Location Santa Clara, California, United States of America Job Description About Surgery: Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. We are seeking a Senior Regulatory Affairs Specialist to support our Robotics and Digital Solutions business. This role will work a Flex/Hybrid schedule and is based in the Santa Clara office. Remote option is not available and relocation assistance is not provided. Responsibilities Ensure compliance with regulatory agency regulations and interpretations. Prepare responses to regulatory agencies’ questions and other correspondence. Gather and assemble information necessary for submissions according to regulations and relevant guidelines. Provide solutions to a variety of moderate‑scope problems. Research, collect data, and respond to requests from regulatory agencies and distributors to prepare and submit documentation for marketing approvals. Provide routine regulatory information to associates and affiliates. Advise on regulatory labeling requirements and review product labeling for compliance. Provide regulatory guidance to project teams and respond to product information requests. Offer Regulatory Affairs support during internal and external audits and help develop best practices. Represent Regulatory Affairs on cross‑functional project teams. Communicate business‑related issues or opportunities to the next management level. Follow all company guidelines related to Health, Safety and Environmental practices. Ensure personal and company compliance with all federal, state, local and company regulations, policies and procedures. Perform other duties assigned as needed. Qualifications & Requirements Minimum of a Bachelor’s Degree required; advanced degree strongly preferred. Field of study in science, biomedical engineering, medical/scientific writing, public health administration is highly desired. At least 4+ years of related regulatory affairs experience (3+ with advanced degree). Experience with healthcare products (consumer, pharmaceutical, or medical device) and regulations is strongly preferred. Knowledge of US (FDA) and OUS (EU MDR) health product regulations is preferred. Previous medical device submission experience is preferred. Ability to work independently and in a team environment to problem‑solve and identify gaps in processes. Leverages scientific and technical understanding of regulated products to provide regulatory input to product lifecycle management and evaluate regulatory impact on products. Demonstrates ability to contribute to effective regulatory strategic plans aligned with business objectives. Consults with others to understand benefits, risks, and Credo‑based impact before making decisions. Provides support to complex projects and makes timely, effective decisions based on available information. Encourages and supports internal collaboration across levels, creating effective solutions. Builds and leverages internal and external networks with cross‑functional partners, industry contacts, and regulatory agencies. Adapts to change and challenges the status quo to have a positive impact. Influences external stakeholders to promote Regulatory perspectives. Acts with speed, flexibility, accountability and manages priorities to deliver results for on‑time clearances. Required Skills Analytical Reasoning Brand Research Business Behavior Design Thinking Detail‑Oriented Industry Analysis Market Research Package and Labeling Regulations Problem Solving Process Oriented Product Packaging Design Project Management Project Support Proof Reading Software Quality Assurance (QA) Regulatory Affairs Management Regulatory Compliance Risk Assessments Safety‑Oriented Preferred Skills Analytical Reasoning Brand Research Business Behavior Design Thinking Detail‑Oriented Industry Analysis Market Research Package and Labeling Regulations Problem Solving Process Oriented Product Packaging Design Project Management Project Support Proof Reading Software Quality Assurance (QA) Regulatory Affairs Management Regulatory Compliance Risk Assessments Safety‑Oriented Compensation & Benefits Anticipated base pay range: $106,000.00 – $170,200.00. Benefits include consolidated retirement plan (401(k)), vacation (120 hours per calendar year), sick time (40 hours per year), additional hours for Colorado and Washington residents, holiday pay (13 days per year), work‑personal‑family time (up to 40 hours per year), parental leave (480 hours within one year), bereavement leave (240 hours), caregiver leave (80 hours), volunteer leave (32 hours), and military spouse time‑off (80 hours). For full details, visit Equal Opportunity 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 inclusive interview process for applicants with disabilities. If you have a disability and would like to request an accommodation, please contact #J-18808-Ljbffr 6267-Auris Health Inc. Legal Entity