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 submissions such as IDE, 510(k), and PMA, while ensuring compliance with FDA and European regulations. Strong communication skills and attention to detail are essential for guiding project teams and resolving regulatory issues.

Highest-signal resume keywords

Regulatory Affairs ExperienceFDA Regulations KnowledgeEuropean Medical Device RegulationsSubmission PreparationMedical Device Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsIDE Preparation510(k) PreparationPMA PreparationTechnical DocumentationRegulatory AssessmentsLabeling ReviewRegulatory GuidanceQuality System RegulationsISO 13485 Knowledge

Soft Skills

Excellent Communication SkillsDetail OrientedAbility to Handle Multiple Tasks

Tools & Technologies

Electronic Submission Preparation

Industry Keywords

Medical DevicesOrthopaedicsCapital EquipmentRoboticsSoftwareMDRMDD

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 or assist with IDE, 510(k), PMA, Technical File, Design Dossier, and Technical Documentation submissions to regional health authorities
Resolve regulatory issues and respond to regulatory agency questions during pre-market product development
Assist with approval documents for rest-of-world registrations and EU CE marking activities
Review engineering changes and prepare internal regulatory assessments for submission decisions
Assess regulatory impacts of manufacturing and product changes and prepare and submit applications
Review product labeling and support information for regulatory compliance
Provide regulatory guidance to project teams, including design control changes and promotional materials
Maintain knowledge of FDA Quality System Regulations, European quality standards, MDR, MDD, and ISO 13485
Communicate business issues or opportunities to the next management level
Follow health, safety, environmental, legal, regulatory, policy, and procedural requirements
Perform other assigned duties

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

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
Equal Opportunity Employer and inclusive interview process with disability accommodations