Regulatory Affairs Project Manager

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).

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.

You have a 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 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 Robotic Process Automation (RPA) and AI preferred.

Experience with Med Tech Regulatory Information Management System.

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

Regulatory Affairs Certification preferred.

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.

The expected salary range for this position based on the primary location of New Jersey is $93,000 and $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. This position also qualifies for the benefits detailed at the link provided below.

Who we are A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together. We believe it's urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we…