Senior Regulatory Affairs Specialist

Johnson & Johnson

Senior Regulatory Affairs Specialist advancing FDA and global approvals for Johnson & Johnson’s OTTAVA medical-device robotics group. Authoring submissions and shaping regulatory strategies.

Posted 8/21/2026full-timeRemote • California, New Jersey, Ohio • 🇺🇸 United StatesSenior💰 $92,000 - $148,350 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Affairs for Medical Devices, including the preparation and submission of FDA documentation and global health authority submissions. Proven ability to develop and implement regulatory strategies while collaborating effectively with cross-functional teams.

Highest-signal resume keywords

Regulatory Affairs ExperienceFDA SubmissionsRegulatory Strategy DevelopmentMedical Device RegulationsHealth Authority Communications

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Hard Skills

Regulatory Submissions510(k) PreparationGlobal Regulatory KnowledgeRegulatory Strategy ImplementationDocumentation Generation

Soft Skills

Effective CommunicationAttention to DetailOrganizational SkillsCollaborationPresentation Skills

Industry Keywords

Medical DeviceRegulatory ComplianceIEC 60601BiocompatibilitySterilization Requirements

About the role

Key responsibilities & impact

Support the Instrumentation & Accessories team under the OTTAVA robotics group
Help Robotics & Digital Solutions reach US and international regulatory new product development approval goals
Address regulatory affairs needs for robotics, instruments, and accessories portfolios
Work with engineering and clinical teams during product development stages
Generate submission-ready documentation and author regulatory submissions
Support health authority communications
Participate in regulatory strategy development
Implement regulatory strategies for new product clearances and approvals
Prepare, write, and file FDA submissions, including 510(k)s, and global health authority technical submissions
Identify issues, communicate project timelines, and address issues affecting registration status
Guide conformance with regulations and guidance documents for product development, claims, labeling, and promotional materials
Assist in developing Regulatory Affairs processes

Requirements

What you’ll need

Minimum of a Bachelor's Degree required; desired areas of study include Science, Engineering, or related field
Minimum of 4+ years of related Regulatory Affairs experience within Medical Device required; 3+ years with Advanced Degree
Experience with medical device regulatory new product submissions required
Demonstrated track record of developing and driving implementation of regulatory strategies
Working knowledge of how global regulations impact product registration
Good communication skills for effective collaboration with cross-functional partners
Ability to correspond and collaborate with J&J colleagues globally
Ability to evaluate new regulatory requirements and regulatory changes and assess business impact
Excellent verbal and written communication skills; strong attention to detail
High organization skills with ability to lead multiple projects/tasks and prioritize effectively
Strong learning skills for complex technology and presentation skills to present complex regulatory strategies clearly
Up to 25% travel required
Previous experience with health authority meetings/interactions preferred
Experience with medical device software guidance, IEC 60601, sterilization, biocompatibility, and reprocessing requirements preferred

Benefits

Comp & perks

Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; 48 hours for Colorado employees; 56 hours for Washington 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
Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar 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