Senior Regulatory Affairs Program Lead – Wound Closure & Healing, MedTech Surgery

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

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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 and develop regulatory strategies that support product development and compliance.

Highest-signal resume keywords

Regulatory Affairs ExpertiseMedical Device SubmissionsFDA SubmissionsRegulatory Strategy DevelopmentLeadership in Cross-Functional Teams

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsClinical DevelopmentMedical Device RegulationsData Analysis for Regulatory SubmissionsLabeling and Claims DevelopmentRegulatory GuidanceProblem-SolvingProject ManagementWriting and Filing DossiersNegotiation with Regulatory Bodies

Soft Skills

Communication SkillsTeam CollaborationDecision-MakingJudgmentAbility to Work Under Deadlines

Certifications & Qualifications

Regulatory Affairs Certification (RAC)

Industry Keywords

Wound ClosureHealthcare ProductsBiomedical EngineeringPublic Health AdministrationCombination ProductsInternational RegistrationsClinical DataRegulatory Agency CorrespondenceQ-SubmissionsIDE and De Novo Submissions

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 submissions supporting global product launches
Lead submissions for 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
Guide regulatory strategy and supporting evidence, including clinical data, for product development and lifecycle change 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, and EU MDR submissions
Collaborate on labeling and claims development and approval
Support internal and external audits
Plan regulatory deliverables and monitor projects through completion
Develop Regulatory Affairs process best practices and solve complex problems
Apply expert knowledge of relevant guidances, regulations, and standards

Requirements

What you’ll need

Minimum of a Bachelors Degree from 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 healthcare products product industry including submissions is required
Science, biomedical engineering, medical/scientific writing, or public health administration field of study desired
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 multi-functional 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
Ability to communicate clearly and accurately to a widely varied audience
Ability to work well under deadlines
Excellent written and communication skills; fluency in English
Good judgment/decision-making and problem-solving ability
Ability to work under own initiative and as a team player
Remote candidates must be able to travel up to 20%

Benefits

Comp & perks

Company consolidated retirement plan (pension)
Savings plan (401(k))
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; 48 hours for Colorado residents; 56 hours for Washington residents
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
Remote work options considered on a case-by-case basis
Up to 20% travel required for remote candidates