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Senior Regulatory Affairs Program Lead (Robotics & Digital Solutions)

6+ years
$105,000 – $169,050
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

πŸ§ͺ Job Title:

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


πŸ“ 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


πŸ“… 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:

πŸš€ 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

πŸ“„ 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.

πŸ”„ 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.


πŸ“š Required Qualifications:

πŸŽ“ 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

βœ… 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%


πŸ’° Compensation:

πŸ’΅ Base Salary Ranges:

  • Cincinnati, OH / Raritan, NJ: $105,000 – $169,050

  • Santa Clara, CA (Bay Area): $121,000 – $194,350

πŸ† 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

πŸ•’ 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

πŸ”— Full Benefits Info


βš–οΈ 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.


β™Ώ Accessibility / Accommodation:

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