Senior Regulatory Affairs Program Lead – MedTech Surgery

Johnson & Johnson

Senior Regulatory Affairs Program Lead providing regulatory guidance for the Monarch Platform at Johnson & Johnson. Supporting robotics and digital solutions with regulatory strategies and submissions.

Posted 6/12/2026full-timeSanta Clara • California • 🇺🇸 United StatesSenior💰 $125,000 - $201,250 per yearWebsite

Tech Stack

Tools & technologies

Cyber Security

About the role

Key responsibilities & impact

Instills and drives a vibrant regulatory culture, working among cross functional groups as a teammate and collaborator
Applies strategic regulatory thinking along with technical expertise to develop and implement regulatory strategies for new product clearances and approvals
Prepares and submits regulatory information required to obtain global market access
Write and file FDA submissions (e.g., Q-submissions, IDEs, 510(k)s)
Serves as a Regulatory Affairs subject matter expert on new product development and engineering design control teams
Conducting reviews and providing expert regulatory feedback for specifications, device testing, risk management, and other relevant documentation in accordance with regulatory requirements and with positioning for regulatory submission
Proactively identify issues, effectively communicate timelines for project completion, and address complex issues that may impact registration status
Conduct regulatory evaluation of changes to devices in accordance with requirements of commercial/operating geography and generate the required regulatory submission
Guides conformance with applicable regulations and guidance documents in product development, support of claims, content labeling, and promotional materials
Assists in the development and enhancement of Regulatory Affairs processes

Requirements

What you’ll need

Minimum of a Bachelor's Degree required, Advanced Degree highly desired
Minimum of 6+ years of related Regulatory Affairs experience within Medical Device is required (4+ years with Advanced Degree)
Experience with Class II medical device regulatory product submissions required
Previous experience with health authority meetings/interactions required
A demonstrated track record of developing and driving implementation of regulatory strategies
Working knowledge of Cybersecurity regulations, requirements for software as a medical device, including devices with AI/ML
Working knowledge of requirements for medical devices that include electronic components and associated testing (IEC 60601)
Excellent communication skills for effective collaboration with cross-functional partners
Strong attention to detail
Advanced analytical and problem-solving skills
High organization skills with the ability to lead multiple projects/tasks simultaneously and effectively prioritize projects and tasks
Strong learning skills for complex technology and presentation skills to allow presentation of complex regulatory strategies in a clear, concise, and comprehensive fashion

Benefits

Comp & perks

Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 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

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

regulatory strategiesFDA submissionsQ-submissionsIDEs510(k)sregulatory evaluationrisk managementIEC 60601Cybersecurity regulationssoftware as a medical device

Soft Skills

communication skillsattention to detailanalytical skillsproblem-solving skillsorganizational skillsproject managementcollaborationpresentation skillsstrategic thinkingleadership

Certifications

Bachelor's DegreeAdvanced Degree