Regulatory Affairs Project Manager

About the Role

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. You will also identify processes that can be improved and simplified, for example, through the use of RPA (Robotic Process Automation).

Responsibilities

• Assist in activities associated with regulatory approval of in vitro diagnostic medical devices in global markets.
• Provide support to currently marketed products, including reviewing 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.
• Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in relevant geographic and discipline areas for 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.
• May assist as the internal regulatory consultant for on-market product issues.
• Assist in review of proposed device changes.
• Some business travel as required.

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.
• IVD device experience is preferred.
• Ability to manage high-complexity work and/or global projects, or equivalent experience.

Preferred Qualifications

• Experience with international regulatory submissions including CE IVD, MD, IDE, 510(k), and PMA submissions.
• Experience with Robotic Process Automation (RPA) and AI.
• Experience with MedTech Regulatory Information Management System.
• Experience working in a cross-functional team setting and cross-cultural environment.
• Regulatory Affairs Certification.

Locations

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

Pay

The expected salary range for this position based on the primary location of New Jersey is $93,000 to $172,900. 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.

Benefits

This position qualifies for the benefits detailed at the provided link.