Senior Regulatory Affairs Specialist - Vision
About The Position
This role provides regulatory support for product lifecycle activities, including modifications, re-registration, and labeling review. The Senior Regulatory Affairs Specialist is responsible for developing regulatory strategies, ensuring compliance, and supporting audits with minimal supervision. The Vision team at Johnson & Johnson is focused on developing the next generation of smarter, less invasive, more personalized treatments for vision care, addressing needs from the pediatric to aging eye. This position operates on a Hybrid/Flex schedule, requiring three days per week on-site, and must be based within a commutable distance of Irvine, CA or Milpitas, CA.
Requirements
- Minimum of a Bachelor’s Degree is required, Scientific Discipline strongly preferred.
- At least 4+ years of relevant related experience within a regulated environment or equivalent experience in another relevant function such as Quality, Medical, Clinical, 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 US FDA required, EU MDR experience preferred.
- Ability to effectively manage multiple projects and priorities.
- Strong communication and regulatory writing skills.
- Strong problem solving skills, interpersonal skills and effective team member.
- Results oriented.
- Ability to drive to completion in adherence to aggressive project schedules.
Nice To Haves
- Scientific Discipline strongly preferred.
- Demonstrated experience with Regulatory LCM and 510k assessments highly desired.
- Prior experience with Class II or Class III Medical Devices strongly preferred.
- EU MDR experience preferred.
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.
Benefits
- medical
- dental
- vision
- life insurance
- short- and long-term disability
- business accident insurance
- group legal insurance
- consolidated retirement plan (pension)
- savings plan (401(k))
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year (or 56 hours for Washington State employees)
- 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 the birth/adoption/foster care of a child
- Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
- Caregiver Leave – 10 days
- Volunteer Leave – 4 days
- Military Spouse Time-Off – 80 hours
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What This Job Offers
Job Type
Full-time
Career Level
Senior
