Global IVD Regulatory Project Lead

Roche; Tucson (AZ); Hybrid; USD 93,000 - 173,000; Full time

Job summary

Roche – Tucson, AZ – is seeking an experienced regulatory affairs professional to support regulatory activities for a broad range of diagnostic products. You will review changes, maintain filings, and help ensure compliance across US and international markets.

The role requires handling PMA/510(k) submissions, CE registrations, and ongoing regulatory documentation while coordinating with researchers, physicians, and regulatory authorities. Hybrid work applies.

Qualifications

• Bachelor’s or Master’s degree in Life Science, Data Science or related subject.
• 5 years of experience in regulatory, development, clinical affairs, quality, or program management in IVD, medical device, or pharma industries.
• Experience in Healthcare regulatory affairs; IVD device experience preferred.
• Can manage high complexity work and/or global projects.

Responsibilities

• Assist in activities associated with regulatory approval of in vitro diagnostic medical devices in global markets.
• Provide support to currently marketed products, including review of changes and documentation for regulatory compliance (US and international).
• Maintain product technical files and ensure compliance with global directives and regulations.
• Assist in submission activities for device regulatory approvals including CE mark, PMAs, 510(k)s, and related reports.
• Acquire and maintain knowledge of applicable regulatory requirements and interface with regulatory authorities as directed.
• May provide regulatory support on project teams and assist in review of labeling changes and advertising.

Job description

Roche – Tucson, AZ – is seeking an experienced regulatory affairs professional to support regulatory activities for a broad range of diagnostic products. You will review changes, maintain filings, and help ensure compliance across US and international markets.

The role requires handling PMA/510(k) submissions, CE registrations, and ongoing regulatory documentation while coordinating with researchers, physicians, and regulatory authorities. Hybrid work applies.