Global Regulatory Affairs Project Manager (IVD/MedTech)

Roche; Indianapolis (IN); Hybrid; USD 85,000 - 157,000; Full time

Job summary

Roche in Indianapolis seeks a Regulatory Affairs professional to drive regulatory approvals and compliance for in vitro diagnostic medical devices across global markets. The role involves maintaining technical files, reviewing changes, and coordinating with regulatory authorities.

The position supports labeling reviews and submission activities, interfaces with agencies, and may participate in cross-functional teams on global projects.

Qualifications

• Bachelor’s or Master’s in Life Science, Data Science, or related field.
• At least 5 years in regulatory, development, clinical affairs, quality, or program management in IVD/medical devices.
• Experience in Healthcare regulatory affairs; IVD experience preferred.
• Ability to manage high-complexity or global projects.

Responsibilities

• Assist in activities associated with regulatory approval of in vitro diagnostic medical devices in global markets.
• Provide support to marketed products, e.g., review engineering changes, labeling, product changes, and documentation for compliance and regulatory approvals.
• Maintain product technical files and ensure compliance with global directives and regulations.
• Assist in submission activities for regulatory approvals; stay updated on applicable requirements.
• Interface with regulatory authorities on regulatory and technical matters; provide support on project teams as needed.
• Help create Global and Network Procedures and policy guidelines.
• Review labeling changes, advertising and promotional activities.
• Review proposed device changes as internal regulatory consultant for on-market issues.
• Occasional business travel as required.

Skills

Regulatory affairs

Regulatory submissions

Project management

Cross-functional collaboration

Healthcare industry knowledge

Education

Bachelor’s or Master’s degree in Life Science or related

Tools

MedTech Regulatory Information Management System

Job description

Roche in Indianapolis seeks a Regulatory Affairs professional to drive regulatory approvals and compliance for in vitro diagnostic medical devices across global markets. The role involves maintaining technical files, reviewing changes, and coordinating with regulatory authorities.

The position supports labeling reviews and submission activities, interfaces with agencies, and may participate in cross-functional teams on global projects.