Regulatory Affairs Project Manager

Roche • Indianapolis, IN

1d • $93,000 - $172,900 • Hybrid

About The Position

In this position, you will have an administrative role in registering and addressing affiliate questions 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, Middle East and Africa. In addition, you will identify processes that can be improved and simplified by e.g. the use of RPA (Robotic Process Automation).

Requirements

• 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.
• 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 Robotic Process Automation (RPA) and AI preferred.
• Experience with MedTech Regulatory Information Management System
• Experience working in a cross-functional team setting and cross culture 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, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to US and 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 including the CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, export certificates, establishment registrations and listings, etc.
• 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 Operating Procedures and policy guidelines.
• Assist in review of labeling changes, advertising and promotional activities, etc.
• May 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.
• This position also qualifies for the benefits detailed at the link provided below.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level