Regulatory Affairs Project Manager
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
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.
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.
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.
Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.