Regulatory Affairs Manager

Johnson & Johnson

Regulatory Affairs Manager ensuring compliance for product launches in Orthopedics at Johnson & Johnson. Providing regulatory guidance and managing submissions for new and existing products.

Posted 7/11/2026full-timeOberdorf • 🇨🇭 SwitzerlandMid-LevelSeniorWebsite

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Regulatory GuidanceRegulatory SubmissionsLabeling Specifications DevelopmentProject ManagementData Evaluation for Approvals

Soft Skills

CommunicationCollaborationLeadership

Certifications

Regulatory Affairs Certification (RAC)