Senior Regulatory Affairs Specialist - Vision

Senior Regulatory Affairs Specialist Location: Irvine, California or Milpitas, California (Hybrid/Flex schedule, 3 days on-site). Purpose The Senior Regulatory Affairs Specialist provides regulatory support for product lifecycle activities, including modifications, re‑registration, and labeling review. Responsible for developing regulatory strategies, ensuring compliance, and supporting audits with minimal supervision. Responsibilities Provides strategic regulatory guidance throughout product lifecycle stages. Leads preparation and submission of licensing, registration, and approval dossiers. Coordinates complex regulatory activities, including post‑market modifications. Ensures conformance of product labeling, claims, and promotional materials. Develops regulatory strategies and plans for new product development. Reviews and approves labeling, packaging, and promotional content. Supports audits and inspections to ensure compliance. Guides and trains junior team members on regulatory processes. Maintains and monitors regulatory compliance across markets. Liaises with health authorities during inspections and inquiries. Tracks regulatory developments and advises on impact. Participates in cross‑functional project teams at a leadership level. May supervise work of contract resources or interns. Qualifications Minimum of a Bachelor’s Degree, preferably in a scientific discipline. At least 4+ years of experience in a regulated environment or an equivalent field such as Quality, Medical, Clinical, or R&D. Demonstrated experience with Regulatory LCM and 510k assessments highly desired. Prior experience with Class II or Class III Medical Devices strongly preferred. Experience interacting directly with the US FDA required; EU MDR experience preferred. Ability to effectively manage multiple projects and priorities. Strong communication and regulatory writing skills. Strong problem‑solving, interpersonal skills and an effective team member. Results‑oriented with ability to drive completion in adherence to aggressive project schedules. Up to 10% travel may be required. Pay Base pay range: $92,000 to $148,350. Benefits Eligible for medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, group legal insurance; consolidated retirement plan and 401(k) savings plan; vacation and sick time; holiday pay and floating holidays; personal and family time; parental leave; condolence leave; caregiver leave; volunteer leave; and military spouse time‑off. Detailed information is available at the company benefits portal. Equal Opportunity Employer 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 any other characteristic protected under 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. #J-18808-Ljbffr