Senior Regulatory Affairs Specialist (Monarch) - MedTech Surgery

Senior Regulatory Affairs Specialist Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional Job Location: Santa Clara, California, United States of America Job Description Senior Regulatory Affairs Specialist to support our Robotics and Digital Solutions business, working a Flex/Hybrid schedule in the Santa Clara office (no remote option). The role provides regulatory guidance to project teams, develops and executes regulatory strategies for new, modified, and marketed medical devices, prepares regulatory documentation for submissions to European Notified Bodies, FDA, and other authorities, and ensures compliance with applicable regulations. Responsibilities Ensures compliance with regulatory agency regulations and interpretations. Prepares responses to regulatory agencies' questions and correspondence. Gathers and assembles information necessary for submissions per regulations and guidelines. Provides solutions to moderate‑scope problems. Researches and collects data, responds to agency/distributor requests, and prepares marketing approval documentation. Advices on regulatory labeling requirements and reviews product labeling for compliance. Provides regulatory guidance to project teams and responds to product information requests. Supports internal and external audits, aids best‑practice development. Represents Regulatory Affairs on cross‑functional project teams. Communicates business‑related issues or opportunities to management. Adheres to Health, Safety and Environmental practices as applicable. Ensures personal and company compliance with all regulations, policies, and procedures. Performs other duties as assigned. Qualifications Minimum Bachelor’s Degree required; Advanced Degree strongly preferred. Field of study in science, biomedical engineering, medical/scientific writing, public health administration highly desired. At least 4+ years of regulatory affairs experience required (3+ with Advanced Degree). Experience with healthcare products (Consumer, Pharmaceutical, or Medical Device) and regulations strongly preferred. Knowledge of US FDA and EU MDR regulations preferred. Prior medical device submission experience preferred. Ability to work independently and in a team, solve problems, and identify process gaps. Leverages scientific and technical understanding to provide regulatory input across product lifecycle. Contributes to effective regulatory strategic plans aligned with business objectives. Consults with others to assess risks, benefits, and Credo‑based impacts before decisions. Supports complex projects and makes timely decisions with minimal guidance. Encourages collaboration across levels, builds internal and external networks. Challenges status‑quo and adapts to change for positive impact. Leads by leveraging diverse perspectives and talent for innovative solutions. Delivers results with speed, flexibility, accountability, and priority management. Skills Analytical reasoning Brand research Business behavior Design thinking Detail orientation 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 orientation Compensation Base pay range: $106,000.00 - $170,200.00 Benefits Summary Vacation: 120 hours per calendar year Sick time: 40 hours per calendar year (48 for Colorado, 56 for Washington) Holiday pay and 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 Bereavement leave: 240 hours for immediate family, 40 hours for extended family per 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 Retirement and savings plans: subject to company plans All other employee benefits available upon request. 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 under VEVRAA and Section 503. #J-18808-Ljbffr