Senior Regulatory Affairs Program Lead (Robotics & Digital Solutions)

Johnson & Johnson

6+ years

$105,000 – $169,050

Cincinnati

10 Sept. 10, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/ B.Pharma/ M.Pharma/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

🧪 Job Title:

Senior Regulatory Affairs Program Lead (Robotics & Digital Solutions)
Company: Johnson & Johnson – MedTech Surgery, Inc.
🔗 Learn More About MedTech

📍 Locations (Hybrid Role):

Preferred: Cincinnati, OH
Other Options: Santa Clara, CA or Raritan, NJ

🏢 Hybrid work schedule: 3 days in-office/week (no remote option)
🚚 Relocation assistance may be available on a case-by-case basis

📅 Job Details:

Function: Regulatory Affairs
Sub-function: Regulatory Affairs
Category: Senior Analyst, Regulatory Affairs (P6)
Requisition Number: R-031917
Work Pattern: Hybrid
Date Posted: September 5, 2025
Anticipated Closing Date: September 12, 2025 (may be extended)

🧭 Job Purpose:

Join Johnson & Johnson’s Robotics & Digital Surgery team and lead regulatory strategy development and execution to gain U.S. and international market approvals. This role will focus on robotic instruments and accessories, including authoring submissions, reviewing technical documentation, and supporting health authority communications.

🎯 Key Responsibilities:

🚀 Regulatory Strategy & Execution

Develop and implement regulatory strategies for new product development (NPD).
Prepare and file regulatory submissions for global market access:
- FDA (510(k), IDEs, De Novo, Q-submissions)
- International regulatory bodies

📄 Documentation & Review

Author and review submission-ready technical documents.
Provide regulatory expertise to cross-functional product development teams, including engineering and clinical.
Support risk management, product specifications, and verification activities.

🤝 Health Authority & Stakeholder Engagement

Act as regulatory subject matter expert in cross-functional and design control meetings.
Conduct regulatory assessments of product changes and determine required submissions.
Communicate effectively with global stakeholders and regulatory authorities.

🔄 Process Improvement & Compliance

Drive a compliant regulatory culture across the organization.
Support internal process improvements within Regulatory Affairs.
Ensure adherence to labeling, advertising/promotional regulations and quality standards.

📚 Required Qualifications:

🎓 Education:

Minimum: Bachelor’s Degree (in Science, Engineering, or related field)
Preferred: Advanced Degree (MS, PhD, or related)

🧠 Experience:

6+ years Regulatory Affairs experience in Medical Devices
(4+ years with advanced degree)
Proven experience with regulatory submissions for medical devices
Deep understanding of:
- Global regulations & submissions
- Engineering design control
- Product registration impacts
Experience in:
- Health authority interactions
- Software-related devices & guidance
- IEC 60601, sterilization, biocompatibility, reprocessing

✅ Skills:

Strong verbal & written communication
High attention to detail
Strong organizational & prioritization abilities
Effective collaboration in a matrixed team environment
Analytical & problem-solving mindset
Presentation skills for complex regulatory strategies
Ability to travel up to 25%

💰 Compensation:

💵 Base Salary Ranges:

Cincinnati, OH / Raritan, NJ: $105,000 – $169,050
Santa Clara, CA (Bay Area): $121,000 – $194,350

🏆 Bonus & Incentives:

Eligible for performance-based annual bonus
Eligible for long-term incentive program

🎁 Employee Benefits (U.S.):

Subject to applicable policies and eligibility:

Medical, Dental, Vision Insurance
Life Insurance and Business Accident Insurance
Short- & Long-Term Disability
Group Legal Insurance
401(k) and Retirement (Pension) Plans

🕒 Time Off:

Vacation: 120 hours/year
Sick Time: 40–56 hours/year (state dependent)
Holidays & Floating Holidays: 13 days/year
Work, Personal, Family Time: 40 hours/year
Parental Leave: 480 hours
Condolence Leave: Up to 30 days
Caregiver Leave: 10 days
Volunteer Leave: 4 days
Military Spouse Time-Off: 80 hours

🔗 Full Benefits Info

⚖️ Equal Opportunity Statement:

Johnson & Johnson is an Equal Opportunity Employer. We encourage applications from all backgrounds, including protected veterans and individuals with disabilities, as defined under VEVRAA and Section 503 of the Rehabilitation Act.

♿ Accessibility / Accommodation:

If you require accommodation during the hiring process due to a disability, please contact:
📧 ra-employeehealthsup@its.jnj.com
Or reach out to AskGS for guidance.

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Senior Regulatory Affairs Program Lead (Robotics & Digital Solutions)

Job Description

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