Senior Regulatory Affairs Specialist – Vision

Johnson & Johnson

Senior Regulatory Affairs Specialist responsible for regulatory compliance and product lifecycle activities. Collaborating with teams to ensure successful product registration and approvals.

Posted 5/14/2026full-timeIrvine • California • 🇺🇸 United StatesSenior💰 $92,000 - $148,350 per yearWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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.
Up to 10% travel may be required.

Benefits

Comp & perks

medical
dental
vision
life insurance
short- and long-term disability
business accident insurance
group legal insurance
pension
savings plan (401(k))
Vacation – 120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory guidancelicensingregistrationapproval dossiersregulatory strategiesregulatory complianceRegulatory LCM510k assessmentsClass II Medical DevicesClass III Medical Devices

Soft Skills

communication skillsregulatory writing skillsproblem solving skillsinterpersonal skillsteam collaborationproject managementresults orientedleadershiptrainingmultitasking

Certifications

Bachelor’s DegreeScientific Discipline