Regulatory Affairs Manager

Johnson & Johnson

Regulatory Affairs Manager guiding independent regulatory strategies for new product launches in MedTech. Leading regulatory compliance and communication with FDA and international agencies.

Posted 7/11/2026full-timePalm Beach Gardens • Florida, Massachusetts, Pennsylvania • 🇺🇸 United StatesMid-LevelSenior💰 $117,000 - $201,250 per yearWebsite

About the role

Key responsibilities & impact

Provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches
Manages the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers
Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials
Defines data and information needed for regulatory approvals
Develops labeling specifications and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations
Plans schedules for regulatory deliverables on a project and monitors project through completion
Leads in the development of best practices for Regulatory Affairs processes
Represents Regulatory Affairs on cross-functional project teams
Partners with other functions to define and obtain data to assist with regulatory submissions
May work with International Affiliates directly
Provide Regulatory Affairs support during internal and external audits
Responsible for communicating business related issues or opportunities to next management level
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Performs other duties assigned as needed

Requirements

What you’ll need

Bachelor’s degree or equivalent
6 years of related experience
Experience in the Medical Device industry or medical field
Experience with power devices is highly preferred
Demonstrated knowledge of US and EU Medical Device Regulations preferred
RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society or advanced degree in Regulatory Affairs, desirable
Ability to travel up to 10% may be required both domestic and international

Benefits

Comp & perks

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
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 period
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

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Hard Skills & Tools

Regulatory GuidanceLabeling Specifications DevelopmentRegulatory Submissions ManagementData Evaluation for ApprovalsCompliance Monitoring

Soft Skills

Cross-Functional CollaborationCommunication SkillsLeadership

Certifications

Regulatory Affairs Certification (RAC)