Senior Regulatory Affairs Specialist

Johnson & Johnson

. Coordinate, compile, and submit medical device and investigational medical device applications to regulatory bodies .

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 and compliance for medical devices, with a strong focus on product lifecycle management and the ability to communicate effectively with internal stakeholders. Proficient in developing regulatory strategies and maintaining regulatory databases while ensuring adherence to applicable laws and standards.

Highest-signal resume keywords

Regulatory SubmissionsProduct Lifecycle ManagementRAC CertificationRegulatory ComplianceRisk-Benefit Analysis

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsProduct Lifecycle ManagementRegulatory ComplianceRisk-Benefit Analysis TechniquesChange Request ReviewMedical Device ListingsSOP DevelopmentRegulatory Strategy DevelopmentRegulatory Database MaintenanceOrthopedic Devices Knowledge

Soft Skills

Excellent Written CommunicationExcellent Oral CommunicationExcellent Organizational SkillsDetail OrientedAbility to Handle Multiple Tasks

Certifications & Qualifications

RAC Certification

Industry Keywords

Medical Device ApplicationsRegulatory AuthoritiesProduct LabelingImport DetentionsCompliance with Laws and Regulations

About the role

Key responsibilities & impact

Coordinate, compile, and submit medical device and investigational medical device applications to regulatory bodies
Provide regulatory input to product lifecycle management and evaluate regulatory impacts on products
Compile, prepare, review, and submit regulatory submissions to authorities
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, 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
Assist in developing and implementing SOPs and systems for product-associated events
Develop and update regulatory strategies based on regulatory changes
Support complex projects and execute project deliverables
Provide regulatory input to product lifecycle planning
Evaluate regulatory history and therapeutic/diagnostic context to assess approval implications
Determine and communicate submission and approval requirements
Advise internal stakeholders on regulatory issues
Identify applicable standards for organizational products
Maintain compliance with applicable laws, policies, regulations, and procedures
Communicate business issues or opportunities to the next management level
Perform other assigned duties

Requirements

What you’ll need

University / bachelor’s degree or equivalent
Generally, 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; 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 careers.jnj.com/employee-benefits