Regulatory Affairs Manager – IVD Instruments and Software

Roche

. Support regulatory projects and strategic topics across Laboratory Instruments, consumables and Software, including integrated hardware and software instrument systems .

Posted 10/9/2026full-timeUnited StatesMid-LevelSenior💰 $106,100 - $197,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Affairs for IVD instruments and software, with a strong focus on USFDA and international regulations. Proven ability to develop innovative regulatory strategies and manage complex global submissions while fostering stakeholder relationships.

Highest-signal resume keywords

Regulatory Affairs ExperienceUSFDA Regulations KnowledgeIVD Instruments ExpertiseStakeholder ManagementGlobal Submission Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Document CompilationSubmission/Product Registration DossiersQuality Standards InterpretationContinuous Improvement Best PracticesMedical Laboratory Instruments Knowledge

Soft Skills

LeadershipConflict ResolutionTeam CollaborationProactive Decision-MakingRelationship Building

Industry Keywords

IVDsMedical DevicesPharmaceuticalsBiopharmaceuticalsGlobal Regulatory Strategies

About the role

Key responsibilities & impact

Support regulatory projects and strategic topics across Laboratory Instruments, consumables and Software, including integrated hardware and software instrument systems
Focus on the Pathology and Digital Pathology portfolio within the Pathology Customer Area
Oversee regulatory document and submission compilation, including submission/product registration dossiers for complex products and programs
Develop and manage parts of comprehensive global regulatory submissions and registration plans
Apply knowledge of USFDA regulations to IVD instruments and software, accessories and system reagents
Interface with external management, customers and stakeholders
Build and maintain external relationships and apply stakeholder management practices
Support audit preparation, execution and follow-up
Lead organizational adaptation to evolving regulatory environments and requirements
Interpret regulators’ thinking and apply regional regulatory strategies
Create innovative regulatory strategies to avoid obstacles and accelerate worldwide approvals
Partner with stakeholders to identify and deliver solutions
Address problems and opportunities and involve collaborators in solutions
Develop relationships influencing Roche’s and its products’ direction
Make decisions independently and initiate activities proactively
Model VAAC Leadership and agility and contribute to an inclusive environment
Bring people together around common goals, resolve conflict and enhance team outcomes

Requirements

What you’ll need

Bachelor’s / Master degree in Life Science, Data Science or related subject or equivalent experience
Advanced degree preferred
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 experiences 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 adequately interpret and implement quality standards considered an advantage
Demonstrated ability to manage more complex work and/or parts of global projects
Experience with medical laboratory instruments, accessories, consumables and software product launch strategies for USFDA, EU and other global geographies preferred
Must be local to Tucson, Indianapolis, Branchburg, or Carlsbad
Relocation assistance is not available

Benefits

Comp & perks

A discretionary annual bonus may be available based on individual and Company performance
Benefits detailed at the link provided below
Equal opportunity employer
Disability accommodation available for the online application process