Senior Regulatory Affairs Program Lead

Johnson & Johnson

Regulatory Affairs Program Lead advancing Johnson & Johnson OTTAVA surgical robotics approvals. Leading global submissions, product strategies, and health authority interactions.

Posted 8/21/2026full-timeRemote • California, New Jersey, Ohio • 🇺🇸 United StatesSenior💰 $109,000 - $174,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Affairs with a focus on medical device submissions, including FDA and global health authority requirements. Proven ability to develop and implement regulatory strategies while effectively collaborating with cross-functional teams.

Highest-signal resume keywords

Regulatory Affairs ExpertiseMedical Device Regulatory SubmissionsRegulatory Strategy DevelopmentFDA Submission PreparationCross-Functional Collaboration

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentFDA SubmissionsIDE Preparation510(k) SubmissionsRisk ManagementRegulatory ComplianceTechnical DocumentationDevice Testing EvaluationRegulatory Change AssessmentHealth Authority Communication

Soft Skills

Effective CommunicationAttention to DetailAnalytical SkillsProblem-Solving SkillsOrganizational Skills

Industry Keywords

Medical DeviceNPD ApprovalGlobal RegulationsIEC 60601BiocompatibilitySterilization RequirementsReprocessing RequirementsHealth Authority MeetingsRegulatory Affairs ProcessesProduct Development

About the role

Key responsibilities & impact

Support the Instrumentation & Accessories team under the OTTAVA robotics group
Help OTTAVA reach US and international regulatory (NPD) approval goals
Lead regulatory strategy development and execution for the robotic instruments and accessories portfolio
Work with engineering and clinical teams throughout product development stages
Generate submission-ready documentation and author regulatory submissions
Support health authority communications
Drive a vibrant regulatory culture across cross-functional groups
Develop and implement regulatory strategies for new product clearances and approvals
Prepare, write, and file FDA submissions, including Q-submissions, IDEs, De Novo, and 510(k)s, as well as global health authority technical submissions
Serve as a Regulatory Affairs subject matter expert on new product development and engineering design control teams
Review specifications, device testing, risk management, and related documentation for regulatory compliance and submission positioning
Identify issues, communicate project timelines, and address complex issues affecting registration status
Evaluate device changes and generate required regulatory submissions, including Letters To File
Guide conformance with regulations and guidance documents in product development, claims support, labeling content, 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 6+ years of related Regulatory Affairs experience within Medical Device required (4+ 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
Experience evaluating new regulatory requirements and regulatory changes and assessing business impact
Excellent verbal and written communication skills; strong attention to detail
Advanced analytical and problem-solving skills
High organization skills with ability to lead multiple projects/tasks simultaneously and prioritize effectively
Strong learning skills for complex technology and presentation skills for explaining complex regulatory strategies clearly, concisely, and comprehensively
Previous experience with health authority meetings/interactions
Experience with medical device software guidance, IEC 60601, sterilization, biocompatibility, and reprocessing requirements and documentation in submissions

Benefits

Comp & perks

Retirement plan (pension)
Savings plan (401(k))
Vacation – 120 hours per calendar year
Sick time – 40 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
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
Up to 25% travel
Remote options considered on a case-by-case basis