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 regulatory documentation such as IDE, 510(k), and PMA. Maintains compliance with FDA Quality System Regulations and European Quality Standards while effectively communicating with regulatory agencies.

Highest-signal resume keywords

Regulatory Affairs ExperienceMedical Device Industry KnowledgeFDA Quality System RegulationsMDR and MDD FamiliarityRegulatory Documentation Preparation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory DocumentationIDE Submission510(k) SubmissionPMA SubmissionTechnical Files PreparationDesign DossiersTechnical DocumentationElectronic Submission PreparationProduct Lifecycle ManagementOrthopedic Implants Knowledge

Soft Skills

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

Certifications & Qualifications

BA/BS Degree

Industry Keywords

Medical DevicesRegulatory ComplianceGlobal Registration ActivitiesPost-Market ActivitiesInternal AuditsExternal AuditsClaims and LabelingPromotional Materials

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
Guide conformance with regulations in product development, claims, labeling, and promotional materials
Review and approve product lifecycle changes affecting devices, design, packaging, and labeling
Review and approve product labeling and support information for marketed products
Maintain knowledge of FDA Quality System Regulations, European Quality Standards, MDR, MDD, and ISO 13485
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
A minimum of 2 years plus medical device industry experience or relevant medical device experience
BA/BS Degree required
Knowledge or familiarity of U.S. FDA and EU Medical Device Regulations MDR (and previous MDD) and presiding guidance’s 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

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