Global IVD Regulatory PM | Cross-Functional Leader

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

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.