In this position, you will have a role in working with internal and Roche affiliates for a wide array of innovative medical diagnostic products for researchers, physicians, patients, hospitals, laboratories, and blood banks in high-profile demographic regions, specifically in APAC,  LATAM, the Middle East, and Africa. In addition, you will identify processes improvements and implementation. 

The Opportunity

• Assist in activities associated with regulatory approval of in vitro diagnostic medical devices in global markets.

• Provide support to currently marketed products, e.g., review engineering changes, labeling, product changes, and documentation for compliance and for changes requiring regulatory agency approval, as per international regulatory requirements.

• Responsible for maintenance of product technical files and for ongoing activities related to compliance with global directives and regulations.

• Assist in submission activities for a variety of device regulatory approvals. Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline as relevant to assigned projects.

• Interface with regulatory authorities on regulatory and technical matters, as directed.

• May provide regulatory support on project teams.

• Assist in the creation of Global and Network  Procedures and policy guidelines.

• Assist in review of labeling changes, advertising and promotional activities, etc.

• Assist as the internal regulatory consultant for on-market product issues.

• Assist in review of proposed device changes.

• Some business travel as required.

Who You Are

• You have a Bachelor’s or Master's degree in Life Science, Data Science, or a 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 is preferred.

• Can manage high-complexity work and/or global projects, or equivalent experience.

Additional Preferred Experience:

• Experience with international regulatory submissions including CE IVD, MD, IDE, 510(k), and PMA submissions is preferred.

• Experience with MedTech Regulatory Information Management System

• Experience working in a cross-functional team setting and cross-cultural setting is preferred.

• Regulatory Affairs Certification preferred.

Locations

This role can be based in Tucson, Branchburg, or Indianapolis. This is a hybrid role; remote work arrangements are not available.

Relocation assistance is not available for this opportunity.

The expected salary range for this position based on the primary location of Arizona is $84,600 and $157,200.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.