Regulatory Affairs Manager - International CDx

Roche

1d • $106,100 - $197,000 • Onsite

About The Position

As an International Regulatory Affairs Manager, you will be a member of the CDx International Regulatory Subchapter and support the delivery of high-quality regulatory submissions for in vitro diagnostic products, including companion diagnostics, to Health Authorities worldwide outside the US and EU. You will secure regulatory approvals, coordinate submission deliverables, maintain product licenses across their life cycles, and provide strategic regulatory input for international requirements. The role is onsite and may be based in Tucson, Branchburg, Carlsbad, Indianapolis, Pleasanton, or Santa Clara. Relocation assistance is not available.

Requirements

• 3–5 years of relevant experience with a PhD, 5–7 years with a master's degree, or 6–8 years with a bachelor's degree in IVDs, medical devices, pharma, or biopharmaceuticals, with significant Regulatory Affairs experience or equivalent.
• Demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.
• Knowledge of European, US, China, and other international regulations, and demonstrated ability to interpret and implement quality standards.
• Demonstrated ability to manage more complex work and/or portions of global projects.

Nice To Haves

• Experience in companion diagnostics.

Responsibilities

• Secure regulatory approvals for products by collaborating with cross-functional teams across defined markets.
• Coordinate and compile submission deliverables on time to keep product registrations aligned with planned timelines.
• Maintain product licenses throughout their life cycles, managing Health Authority notifications and submissions in accordance with quality management change control processes.
• Improve the efficiency and success of regulatory strategies through partnerships with internal stakeholders, Health Authorities, and Notified Bodies.
• Provide strategic regulatory input based on international requirements and support global submissions by managing data, addressing Health Authority inquiries, and informing international affiliates of key project updates.
• Serve as a subject matter expert and communicate, implement, and maintain transparency around complex regulatory requirements and strategic goals.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• The position qualifies for company benefits, with details provided through a linked resource.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager