Regulatory Affairs Specialist II

Johnson & Johnson

. Execute regulatory activities supporting currently marketed devices and new product development for DePuy Synthes Joint Reconstruction and VELYS Digital Surgery products .

Posted 10/13/2026full-timeUnited StatesJuniorMid-Level💰 $76,000 - $121,900 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Affairs for medical devices, including preparation of regulatory documentation and compliance with US FDA and European regulations. Proficient in managing submissions, resolving regulatory issues, and providing guidance on product information and labeling.

Highest-signal resume keywords

Regulatory Affairs ExperienceUS FDA RegulationsEuropean Medical Device RegulationsKnowledge of ISO 13485Electronic Submission Preparation

ATS Keywords

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Hard Skills

Regulatory Documentation PreparationIDE Submission510(k) SubmissionPMA SubmissionTechnical File PreparationDesign Dossier PreparationRegulatory Impact AssessmentProduct Labeling ReviewRegulatory GuidanceQuality System Regulations

Soft Skills

Excellent Written CommunicationExcellent Oral CommunicationDetail OrientedAbility to Handle Multiple Tasks

Industry Keywords

Medical DevicesOrthopaedicsCapital EquipmentRoboticsSoftwareEU CE MarkingHealth Safety and Environmental ComplianceRegulatory Agencies InteractionMDDMDR

About the role

Key responsibilities & impact

Execute regulatory activities supporting currently marketed devices and new product development for DePuy Synthes Joint Reconstruction and VELYS Digital Surgery products
Prepare and/or assist with regulatory documentation for IDE, 510(k), PMA, Technical File, Design Dossier, and Technical Documentation submissions to regional health authorities
Resolve regulatory issues and questions from regulatory agencies during pre-market product development and interact with agencies regarding submissions
Assist with approval documents supporting rest-of-world registrations, including EU CE marking activities
Review engineering changes to marketed products and prepare internal regulatory assessments regarding submission decisions
Determine regulatory impact of manufacturing and product changes, prepare and submit applications, and assess effects on regulatory licenses
Review product labeling and support information for consistency with clearances, approvals, regulations, and guidance
Provide product information and regulatory guidance to project teams, including design control changes, promotional material review, and regulatory pathway communication
Maintain current knowledge of applicable regulatory and corporate standards and requirements
Communicate business-related issues or opportunities to the next management level
Follow Health, Safety and Environmental practices and ensure compliance with applicable regulations and Company procedures
Perform other duties as assigned

Requirements

What you’ll need

BA/BS degree with minimum 2 years Regulatory Affairs experience in medical devices.
Experience with US FDA Regulations and European Medical Device Regulations (and previous Medical Device Directives) required
Excellent written and oral communications skills
Ability to handle multiple tasks and be detail oriented
Knowledge of medical devices, with preference for orthopaedics, capital equipment, robotics, and software
Familiarity with electronic submission preparation
Knowledge of FDA Quality System Regulations, European Quality Standards and Medical Device Regulation, previous MDD, MDR, and ISO 13485
Ability to comply with applicable federal, state, local, and Company regulations, policies, and procedures

Benefits

Comp & perks

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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Access to Company benefits; details at https://www.careers.jnj.com/employee-benefits
Hybrid Work