Regulatory Affairs Project Manager

Jobtailor; Arizona; On-site; USD 110,000 - 170,000; Full time

Job summary

Jobtailor seeks an experienced Regulatory Affairs professional to lead global submissions for in vitro diagnostic medical devices. You will collaborate with internal teams and affiliates across regions, ensuring compliance with CE IVD, MD, IDE, 510(k), and PMA requirements.

Responsibilities include maintaining technical files, reviewing labeling and promotional materials, guiding cross‑functional teams, and interfacing with regulatory authorities. Some travel will be required as projects demand.

Qualifications

• Bachelor's or Master's degree in Life Science, Data Science, or related subject
• 5+ years of regulatory, development, clinical affairs, quality, or program management in IVD/medical device/pharma industries
• Experience in Healthcare regulatory affairs
• Ability to manage high-complexity work and/global projects
• Experience with international regulatory submissions including CE IVD, MD, IDE, 510(k), and PMA
• Experience with MedTech Regulatory Information Management System
• Experience working in a cross-functional and cross-cultural setting
• Regulatory Affairs Certification preferred
• Some business travel as required

Responsibilities

• Oversee regulatory submissions and project regulatory planning
• Maintain technical files and ensure ongoing compliance
• Review labeling, advertising, and promotional materials for compliance
• Interface with regulatory authorities and provide regulatory consulting
• Collaborate with cross-functional teams across regions
• Support global product changes and lifecycle management

Skills

Regulatory Affairs Certification

International Regulatory Submissions

In Vitro Diagnostic Medical Devices

Healthcare Regulatory Affairs

MedTech Regulatory Information

Education

Bachelor's or Master's degree in Life Science or Data Science

Tools

MedTech Regulatory Information Management System

Job description

• Work with internal teams and Roche affiliates on innovative medical diagnostic products in APAC, LATAM, the Middle East, and Africa
• Identify process improvements and support implementation
• Assist with regulatory approval activities for in vitro diagnostic medical devices in global markets
• Support currently marketed products by reviewing engineering changes, labeling, product changes, and compliance documentation
• Maintain product technical files and perform ongoing compliance activities related to global directives and regulations
• Assist with submissions for a variety of device regulatory approvals
• Maintain current knowledge of applicable regulatory requirements and scientific/technical issues
• Interface with regulatory authorities on regulatory and technical matters as directed
• Provide regulatory support on project teams
• Assist in creating Global and Network Procedures and policy guidelines
• Review labeling changes, advertising, and promotional activities
• Serve as an internal regulatory consultant for on-market product issues
• Review proposed device changes
• Travel for business 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
• Ability to manage high-complexity work and/or global projects, or equivalent 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
• Some business travel as required

Core Competencies

Demonstrates expertise in regulatory affairs for in vitro diagnostic medical devices, including international submissions and compliance with global regulations. Proven ability to manage complex projects and collaborate effectively in cross-functional and cross-cultural teams.

Highest-signal resume keywords

• Regulatory Affairs Certification
• International Regulatory Submissions
• In Vitro Diagnostic Medical Devices
• Healthcare Regulatory Affairs
• MedTech Regulatory Information Management System

Hard Skills

• Regulatory Approval Activities
• Compliance Documentation
• Technical File Maintenance
• Process Improvement
• Project Management

Soft Skills

• Cross-Functional Team Collaboration
• Communication Skills

Certifications & Qualifications

• Regulatory Affairs Certification

Industry Keywords

• Medical Device
• Pharma
• IVD
• Global Directives
• CE IVD
• MD
• IDE
• 510(k)
• PMA