Regulatory Affairs Project Manager

Roche; Indianapolis (IN); Hybrid; USD 85,000 - 157,000; Full time

Job summary

Roche in Indianapolis seeks a Regulatory Affairs professional to drive regulatory approvals and compliance for in vitro diagnostic medical devices across global markets. The role involves maintaining technical files, reviewing changes, and coordinating with regulatory authorities.

The position supports labeling reviews and submission activities, interfaces with agencies, and may participate in cross-functional teams on global projects.

Qualifications

• Bachelor’s or Master’s in Life Science, Data Science, or related field.
• At least 5 years in regulatory, development, clinical affairs, quality, or program management in IVD/medical devices.
• Experience in Healthcare regulatory affairs; IVD experience preferred.
• Ability to manage high-complexity or global projects.

Responsibilities

• Assist in activities associated with regulatory approval of in vitro diagnostic medical devices in global markets.
• Provide support to marketed products, e.g., review engineering changes, labeling, product changes, and documentation for compliance and regulatory approvals.
• Maintain product technical files and ensure compliance with global directives and regulations.
• Assist in submission activities for regulatory approvals; stay updated on applicable requirements.
• Interface with regulatory authorities on regulatory and technical matters; provide support on project teams as needed.
• Help create Global and Network Procedures and policy guidelines.
• Review labeling changes, advertising and promotional activities.
• Review proposed device changes as internal regulatory consultant for on-market issues.
• Occasional business travel as required.

Skills

Regulatory affairs

Regulatory submissions

Project management

Cross-functional collaboration

Healthcare industry knowledge

Education

Bachelor’s or Master’s degree in Life Science or related

Tools

MedTech Regulatory Information Management System

Job description

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.

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.

Salary

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.

Benefits

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.

Equal Opportunity

\"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.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.