Global Regulatory Affairs Manager – Diagnostics

Roche; Indianapolis (IN); Hybrid; USD 106,000 - 197,000; Full time

Job summary

Roche is seeking a Regulatory Affairs professional to advance regulatory submissions for complex instruments, software and related products. You will collaborate across functions and regions to shape regulatory pathways and support patient access to diagnostics.

Ideal candidates have 3–8 years in Regulatory Affairs with strong knowledge of US FDA and international regulations, and a track record in strategy development and audits. Hybrid work in multiple US locations is available.

Qualifications

• Bachelor's or Master's degree in Life Science, Data Science or related field. Advanced degree preferred.
• 3–8 years of regulatory affairs experience in IVDs/Medical devices/Pharma/Biopharmaceuticals.
• Knowledge of European, US, China and other international regulations is advantageous.
• Experience with Daily Management and Continuous Improvement practices.

Responsibilities

• Oversee regulatory document and submission compilation for complex products/programs.
• Interface with external management and stakeholders, maintaining strong external relationships.
• Contribute to audits by supporting preparation, execution and follow-up.
• Lead adaptation to evolving regulatory environments and apply regulators' thinking to projects.
• Develop innovative regulatory strategies to accelerate worldwide approvals.
• Partner with stakeholders to deliver best solution and drive project direction.

Skills

Regulatory affairs

US FDA regulations

Stakeholder management

Regulatory strategy

Audits & compliance

Education

Bachelor's or Master in Life Science

Advanced degree preferred

Job description

Roche is seeking a Regulatory Affairs professional to advance regulatory submissions for complex instruments, software and related products. You will collaborate across functions and regions to shape regulatory pathways and support patient access to diagnostics.

Ideal candidates have 3–8 years in Regulatory Affairs with strong knowledge of US FDA and international regulations, and a track record in strategy development and audits. Hybrid work in multiple US locations is available.