Senior Regulatory Affairs Program Lead – MedTech Surgery

Johnson & Johnson

Senior Regulatory Affairs Program Lead developing regulatory strategies for medical devices at Johnson & Johnson. Collaborating with teams to ensure compliance and market access for innovative health solutions.

Posted 6/12/2026full-timeRemote • 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.
Proactively identify issues, effectively communicate timelines for project completion, and address complex issues that may impact registration status.
Guide 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
Minimum of 6+ years of related Regulatory Affairs experience within Medical Device is required
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.
Evaluating new regulatory requirements as well as regulatory changes and correctly assessing business impact.

Benefits

Comp & perks

Pension and 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
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

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Hard Skills & Tools

regulatory strategiesFDA submissionsQ-submissionsIDEs510(k)sregulatory affairs processesmedical device submissionsCybersecurity regulationsIEC 60601software as a medical device

Soft Skills

communication skillsattention to detailcollaborationstrategic thinkingproblem-solvingproject managementissue identificationtimelines managementcross-functional teamworkregulatory change assessment

Certifications

Bachelor's Degree