Regulatory Affairs Project Manager
Roche•Indianapolis, IN
•$84,600 - $157,200•Hybrid
About The Position
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.
Requirements
- 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.
- Can manage high-complexity work and/or global projects, or equivalent experience.
Nice To Haves
- IVD device experience is preferred.
- 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.
Responsibilities
- 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.
Benefits
- A discretionary annual bonus may be available based on individual and Company performance.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
