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Regulatory Affairs Manager
Johnson & JohnsonRegulatory Affairs Manager ensuring compliance for product launches in Orthopedics at Johnson & Johnson. Providing regulatory guidance and managing submissions for new and existing products.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Regulatory Affairs, including guidance on product development, compliance with US and EU Medical Device Regulations, and management of regulatory submissions. Proven ability to collaborate with cross-functional teams and lead best practices in regulatory processes.
Highest-signal resume keywords
Regulatory Affairs Certification (RAC)US Medical Device RegulationsEU Medical Device RegulationsMedical Device Industry ExperiencePower Devices Experience
ATS Keywords
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Hard Skills
Regulatory GuidanceRegulatory SubmissionsLabeling Specifications DevelopmentProject ManagementData Evaluation for Approvals
Soft Skills
CommunicationCollaborationLeadership
Certifications & Qualifications
Regulatory Affairs Certification (RAC)
Industry Keywords
Medical DeviceInternational RegistrationsDossiersHealth, Safety and Environmental PracticesCross-Functional Teams
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
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
Benefits
Comp & perks- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development opportunities