Senior Regulatory Affairs Specialist – Wound Closure, Healing

Johnson & Johnson

. Provide regulatory guidance to project teams for strategic planning and submissions supporting Ethicon Wound Closure & Healing products .

Posted 10/14/2026full-timeRemote • New Jersey • United StatesSenior💰 $92,000 - $148,350 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing and executing global regulatory strategies for medical devices, ensuring compliance with health authority regulations, and preparing regulatory documentation for submissions. Strong ability to communicate effectively and collaborate across functions to advance regulatory objectives.

Highest-signal resume keywords

Regulatory Affairs ExperienceMedical Device SubmissionRegulatory Strategy DevelopmentCompliance with FDA and European MDRExcellent Written and Verbal Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Documentation PreparationRegulatory ComplianceData Research and CollectionRegulatory Labeling RequirementsRegulatory Agency CorrespondenceSubmission Information AssemblyRegulatory Impact EvaluationLifecycle ManagementAudit SupportRegulatory Affairs Best Practices

Soft Skills

Problem-Solving AbilityGood JudgmentDecision-MakingTeam CollaborationAbility to Work Under Deadlines

Certifications & Qualifications

Bachelor’s Degree

Industry Keywords

Healthcare Products RegulationsUS and OUS RegulationsEthicon Wound Closure & Healing ProductsEuropean Notified BodyBSI

About the role

Key responsibilities & impact

Provide regulatory guidance to project teams for strategic planning and submissions supporting Ethicon Wound Closure & Healing products
Develop and execute global regulatory strategies for new, modified, and marketed medical devices
Prepare regulatory documentation for submissions to health authorities, including European Notified Body, BSI, European MDR, and FDA
Ensure compliance with regulatory agency regulations and interpretations
Prepare responses to regulatory agency questions and correspondence
Gather and assemble submission information according to regulations and guidelines
Research and collect data and respond to regulatory agency and distributor requests
Advise on regulatory labeling requirements and review product labeling for compliance
Provide regulatory guidance to project teams and respond to product information requests
Support internal and external audits and help develop Regulatory Affairs best practices
Represent Regulatory Affairs on cross-functional project teams
Evaluate regulatory impacts on products and contribute to regulatory strategies and lifecycle management
Support complex projects, prioritize deliverables, and solve regulatory problems
Collaborate across functions and levels to advance regulatory objectives
Improve and simplify Regulatory Affairs processes while maintaining controls and compliance

Requirements

What you’ll need

Minimum of a Bachelor’s Degree from an accredited college or university is required
At least 4+ years of regulatory affairs or related/equivalent experience is required; 2+ years with an Advanced Degree
Experience with healthcare products and industry regulations is required
Knowledge of US and OUS health products regulations is preferred
Previous medical device submission experience is preferred
Ability to work independently and in a team environment
Ability to communicate clearly and accurately, verbally and in writing, 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 work in the United States for the right candidate, with up to 10% travel required

Benefits

Comp & perks

Retirement plan (pension)
Savings plan (401(k))
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; 48 hours for employees residing in Colorado; 56 hours for employees residing in Washington
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 10% travel