Senior Regulatory Affairs Specialist – Vision

Johnson & Johnson

Senior Regulatory Affairs Specialist providing regulatory support through product lifecycle stages at Johnson & Johnson. Leading submission of licensing and guiding junior team members in a hybrid role.

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 required, Scientific Discipline strongly preferred.
At least 4+ years of relevant related experience within a regulated environment.
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.
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.

Benefits

Comp & perks

medical, dental, vision, life insurance
short- and long-term disability
business accident insurance
group legal insurance
consolidated retirement plan (pension)
savings plan (401(k))
120 hours vacation per year
40 hours sick time per year
13 days holiday pay per year
up to 40 hours personal and family time per year
480 hours parental leave
30 days condolence leave
10 days caregiver leave
4 days volunteer leave
80 hours military spouse time-off

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory guidancelicensingregistrationapproval dossiersregulatory strategiesregulatory complianceregulatory writing510k assessmentsClass II Medical DevicesClass III Medical Devices

Soft Skills

communication skillsproblem-solving skillsinterpersonal skillsteam collaborationproject managementresults orientedleadershiptrainingmultitaskingadherence to schedules

Certifications

Bachelor’s DegreeScientific Discipline