Senior Regulatory Affairs Specialist

Johnson & Johnson

. Coordinate, compile, prepare, review, and submit medical device and investigational medical device applications to regulatory authorities .

Posted 10/21/2026full-timeUnited StatesSenior💰 $109,000 - $174,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory submissions for medical devices, including preparation and review of applications, compliance with regulations, and development of regulatory strategies. Strong communication and organizational skills are essential for interfacing with product development and managing multiple tasks effectively.

Highest-signal resume keywords

Regulatory SubmissionsMedical Device ApplicationsRAC CertificationRisk-Benefit AnalysisProduct Lifecycle Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentChange Request ReviewProduct Labeling ApprovalRegulatory Database MaintenanceSOP DevelopmentMedical Device Listings PreparationReport SubmissionInvestigational Device ApplicationsOrthopedic Device RegulationsSubmission Requirements Determination

Soft Skills

Excellent Written CommunicationExcellent Oral CommunicationOrganizational SkillsDetail OrientedProblem-Solving

Certifications & Qualifications

RAC Certification

Industry Keywords

Regulatory ComplianceMedical Device RegulationsProduct Lifecycle PlanningNPD/NPI ActivitiesImport DetentionsTherapeutic Context AssessmentOrganizational StandardsProject DeliverablesStakeholder AdvisingRegulatory History Investigation

About the role

Key responsibilities & impact

Coordinate, compile, prepare, review, and submit medical device and investigational medical device applications to regulatory authorities
Provide regulatory input to product lifecycle management, product lifecycle planning, and NPD/NPI activities
Monitor and submit applicable reports and responses to regulatory authorities for orthopedic devices
Interface with Product Development to obtain information for regulatory submissions
Review and approve change requests/notices and determine submission requirements
Review and approve product labeling, including device labels, brochures, technique guides, bulletins, and updates
Prepare registration documents, medical device listings, and annual establishment registrations
Respond to requests for information on import detentions
Maintain the regulatory database with ongoing regulatory information updates
Assist in developing and implementing SOPs and systems for tracking product-associated events
Develop regulatory strategies and update them based on regulatory changes
Support complex projects and execute project deliverables
Investigate regulatory history and therapeutic/diagnostic context to assess approval implications
Determine and communicate submission and approval requirements
Advise internal stakeholders and problem-solve regulatory issues
Identify standards for organizational products
Communicate business issues or opportunities to the next management level
Ensure compliance with applicable laws, regulations, policies, and procedures
Perform other assigned duties

Requirements

What you’ll need

University / bachelor’s degree or equivalent
Generally requires 4–6 years’ work experience
Excellent written and oral communication skills
Excellent organizational skills preferred
Ability to handle multiple tasks and be detail oriented
Ability to apply risk-benefit analysis techniques
RAC certification for Medical Devices preferred

Benefits

Comp & perks

Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; 48 hours per calendar year for employees residing in Colorado; 56 hours per calendar year 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
Company benefits information provided at careers.jnj.com/employee-benefits
Hybrid work arrangement