Regulatory Affairs Manager – International CDx

Roche

. Support and deliver high-quality regulatory submissions of IVDs, including companion diagnostics, to Health Authorities worldwide outside the US/EU .

Posted 11/10/2026full-timeUnited StatesMid-LevelSenior💰 $106,100 - $197,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in regulatory submissions for IVDs and medical devices, with a strong focus on international regulations and quality management processes. Proven ability to collaborate with cross-functional teams and manage complex projects while maintaining compliance and transparency.

Highest-signal resume keywords

Regulatory Affairs ExperienceIVD Submission ManagementKnowledge of International RegulationsQuality Standards ImplementationCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsIVDsCompanion DiagnosticsQuality ManagementContinuous ImprovementProject ManagementData ManagementRegulatory Strategy DevelopmentHealth Authority NotificationsProduct License Maintenance

Soft Skills

CommunicationCollaborationTransparencyProblem-SolvingStakeholder Management

Industry Keywords

Medical DevicesPharmaceuticalsBiopharmaceuticalsEuropean RegulationsUS RegulationsChina RegulationsQuality StandardsRegulatory ApprovalsHealth AuthoritiesNotified Bodies

About the role

Key responsibilities & impact

Support and deliver high-quality regulatory submissions of IVDs, including companion diagnostics, to Health Authorities worldwide outside the US/EU
Secure regulatory approvals by collaborating with cross-functional teams across defined markets
Coordinate and compile submission deliverables to keep product registrations on track with planned timelines
Maintain product licenses throughout their life cycle
Manage Health Authority notifications and submissions according to quality management change control processes
Drive regulatory strategies through partnerships with internal stakeholders, Health Authorities, and Notified Bodies
Provide strategic regulatory input based on international requirements
Support global submissions by managing data and addressing Health Authority inquiries
Keep international affiliates informed of key project updates
Serve as a subject matter expert and communicate, implement, and maintain transparency around complex regulatory requirements and strategic goals

Requirements

What you’ll need

3-5 years experience with PhD degree, 5-7 with Masters degree and 6-8 years with Bachelor degree in IVDs/Medical devices/Pharma/Biopharmaceutical with significant experience in Regulatory Affairs or equivalent
Demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices
Knowledge of European, US, China and other international regulations
Demonstrated ability to interpret and implement quality standards
Demonstrated ability to manage more complex work and/or parts of global projects
Experience in companion diagnostics is a plus

Benefits

Comp & perks

Discretionary annual bonus may be available based on individual and Company performance
Benefits detailed at the provided link
Relocation Assistance is not available for this opportunity