Senior Regulatory Affairs Program Lead – Wound Closure, Healing

Johnson & Johnson

. Own end-to-end lifecycle maintenance and new product development launches for the Wound Closure and Healing portfolio .

Posted 10/14/2026full-timeRemote • New Jersey • United StatesSenior💰 $109,000 - $174,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in regulatory affairs with a focus on medical device submissions, including FDA and EU MDR processes. Proven ability to lead cross-functional teams, manage product lifecycle, and provide strategic regulatory guidance.

Highest-signal resume keywords

Regulatory Affairs ExpertiseMedical Device SubmissionsFDA Submission PreparationEU MDR Submission ExperienceRegulatory Affairs Certification (RAC)

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

Regulatory SubmissionsClinical Data AnalysisLifecycle Change ManagementLabeling and Claims DevelopmentRegulatory GuidanceData Supporting Regulatory SubmissionsProblem SolvingProject ManagementRegulatory Standards KnowledgeNegotiation with Regulatory Bodies

Soft Skills

Effective CommunicationLeadershipTeam CollaborationDecision-MakingMotivated Self-Starter

Certifications & Qualifications

Regulatory Affairs Certification (RAC)

Industry Keywords

Healthcare Products IndustryCombination ProductsMedium- and High-Risk DevicesRegulatory Agency InteractionInternal and External Audits

About the role

Key responsibilities & impact

Own end-to-end lifecycle maintenance and new product development launches for the Wound Closure and Healing portfolio
Provide independent regulatory guidance for strategic planning, pre-marketing, and regulatory submissions
Lead submissions of licenses, authorizations, international registrations, and dossiers for medical devices
Represent Regulatory Affairs on cross-functional teams and serve as a regulatory subject matter expert
Define and obtain data supporting regulatory submissions, including clinical data
Guide New Product Development and Lifecycle Change Management projects
Prepare expert responses to regulatory agency questions and correspondence
Prepare, write, and file FDA submissions, including Q-submissions, IDEs, De Novo, and 510(k)s
Prepare and submit EU MDR submissions
Collaborate on labeling and claims development and approval
Provide Regulatory Affairs support during internal and external audits
Plan regulatory deliverable schedules and monitor projects through completion
Develop Regulatory Affairs process best practices and solve complex problems
Apply expert knowledge of relevant guidances, regulations, and standards
Identify and resolve regulatory challenges and engage internal and external stakeholders
Promote continuous learning, cross-functional collaboration, and effective communication

Requirements

What you’ll need

Minimum of a Bachelor's Degree from an accredited college or university is required
At least 6+ years of regulatory affairs or related/equivalent experience is required; 4+ years with an Advanced Degree
Experience in the healthcare products industry, including submissions, is required
Experience with clinical development strongly preferred
Previous medical device submission experience for medium- and high-risk devices preferred
Demonstrated track record of leadership success strongly preferred
Experience leading multifunctional teams preferred
Previous experience with combination products preferred
RAC (Regulatory Affairs Certification) is desirable
Experience working and negotiating with regulatory bodies is desirable
Ability to work independently and in a team environment to solve problems and identify process gaps
Ability to communicate clearly and accurately, verbally and in writing, to varied audiences
Ability to work well under deadlines
Excellent written and communication skills; fluency in English
Good judgment, decision-making, and problem-solving ability
Motivated self-starter able to work independently and as a team player
Remote candidate must be able to accommodate up to 20% travel

Benefits

Comp & perks

Fully remote work options considered on a case-by-case basis
Retirement plan (pension)
Savings plan (401(k))
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; 48 hours for Colorado employees; 56 hours for Washington employees
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 20% travel