Senior Regulatory Affairs Specialist

Johnson & Johnson

. Support regulatory activities for new, modified, and currently marketed medical devices in the DePuy Joint Reconstruction portfolio .

Posted 10/13/2026full-timeUnited StatesSenior💰 $79,000 - $127,650 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs for medical devices, including preparation and submission of IDE, 510(k), PMA, and compliance with FDA and EU regulations. Proficient in managing product lifecycle changes and ensuring adherence to quality standards and regulatory requirements.

Highest-signal resume keywords

Regulatory Affairs ExperienceMedical Device Regulations KnowledgeIDE, 510(k), PMA Submission PreparationFDA Quality System Regulations FamiliarityOrthopedic Implants Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Documentation PreparationTechnical File DevelopmentProduct Lifecycle ManagementElectronic Submission PreparationRegulatory Compliance Review

Soft Skills

Excellent Written CommunicationExcellent Oral CommunicationDetail OrientedSelf-MotivatedAbility to Handle Multiple Tasks

Certifications & Qualifications

BA/BS DegreeAdvanced Degree Preferred

Industry Keywords

Medical DevicesDePuy Joint ReconstructionHealth Care Compliance ProgramISO 13485MDDEuropean Quality StandardsPost-Market ActivitiesRegulatory Agencies InteractionGlobal Registration ActivitiesOrthopedic Implants

About the role

Key responsibilities & impact

Support regulatory activities for new, modified, and currently marketed medical devices in the DePuy Joint Reconstruction portfolio
Prepare regulatory documentation for IDE, 510(k), PMA, Technical Files, Design Dossiers, and Technical Documentation submissions
Resolve regulatory issues and questions from regulatory agencies during pre-market product development
Support preparation, writing, and submission of global registration activities for Japan, China, Australia, and New Zealand
Ensure compliance with applicable laws, regulations, company policies, and the Health Care Compliance Program and Code of Conduct
Guide conformance with regulations in product development, claims, labeling content, and promotional materials
Review and approve Product Lifecycle Management System changes affecting devices, design, packaging, and labeling
Review product labeling and support information for marketed products for regulatory compliance
Maintain current knowledge of FDA Quality System Regulations, European Quality Standards, Medical Device Regulation, ISO 13485, and MDD
Support post-market activities and lead external and internal audits
Perform other duties as assigned

Requirements

What you’ll need

Minimum of 2 years plus prior relevant regulatory affairs or experience in medical devices, preferred
A minimum of 2 years plus medical device industry experience or relevant medical device experience
Knowledge or familiarity of U.S. FDA and EU Medical Device Regulations MDR (and previous MDD) and presiding guidance and standards a plus
Knowledge of orthopedic implants a plus
Familiarity with electronic submission preparation a plus
Excellent written and oral communication skills
Ability to handle multiple tasks, self-motivate and be detail oriented
BA/BS Degree required; advanced degree or equivalent work experience preferred

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
Employee benefits information available at https://www.careers.jnj.com/employee-benefits