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Regulatory Affairs Manager - PHCS

Oro Valley, AZ 85755

Posted: 09/02/2026 Employment Type: Contract Industry: Quality and Regulatory Affairs Job Number: 12813 Pay Rate: $45.00 - $55.00 Remote Friendly: Remote

Job Description

Our client develops, manufactures and supplies a wide array of innovative medical diagnostic products, services, tests, platforms and technologies.

Role Overview:

As a key member of the Regulatory Affairs team, you will secure and maintain regulatory approvals for software and instrument products within your area of responsibility. You will drive success through strategic cross-functional collaboration, efficient lifecycle management, and a commitment to innovation and strong leadership principles.

Key Responsibilities:
  • Submission & Compliance: Oversee the development of complex registration dossiers and global submission plans. Manage the full product lifecycle, ensuring compliance through robust change controls.
  • Regulatory Strategy: Develop innovative strategies to accelerate global approvals. Anticipate regulatory hurdles, interpret health authority expectations, and navigate complex, high-stakes issues.
  • Stakeholder & External Engagement: Build influential relationships with internal and external partners. Negotiate win-win outcomes, actively manage audit preparations, and represent client interests externally.
  • Decision-Making & Problem-Solving: Exercise sound judgment and courage in decision-making, often with incomplete information. Proactively identify risks, implement cost-effective solutions, and push decision-making to the appropriate level.
  • Leadership & Team Culture: Foster an inclusive team environment, mentor junior staff, champion data stewardship, and drive the adoption of new technologies to increase productivity.
  • Communication: Clearly articulate complex ideas, resolve conflicts with transparency, and build trust across diverse teams.

Job Requirements

Candidate Requirements:
  • 3-5 years experience with a PhD degree; 5-7 with Master's degree or 6-8 years with Bachelor's degree in the field of IVDs/Medical Devices/Pharma/Biopharmaceutical with significant experience in Regulatory Affairs or equivalent.
  • Previous regulatory experience with FDA submissions for software or instrumentation in the medical device, biotech, or in-vitro diagnostics industry.
  • Exceptional stakeholder management, communication, and conflict navigation.
  • Has demonstrated the ability to manage high complexity work and/or global projects.
  • Knowledge of the European, U.S., China and other international regulations and demonstrated ability to adequately interpret and implement quality standards considered an advantage.

Meet Your Recruiter

Lexie Pierce
Senior Recruiter

As a Compass recruiter, Lexie brings in 15 years of experience in leadership and employee growth and development. She's incredibly passionate about helping candidates find and accept new opportunities, ultimately leading her to start her recruiting career in the life science industry. Her favorite part about connecting with Compass candidates and clients is witnessing the excitement the candidates exude and making an impact on their lives.

 

Outside of the office, Lexie enjoys going to the farmers' market on Saturdays with her son so she can find the best produce to use in her family dinners. She enjoys cooking, reading, knitting, restoring furniture, and spending time with her family and friends. Lexie is also passionate about supporting organizations that are looking to educate the community about Congenital Heart Defects (CHD).

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About Oro Valley, AZ

Ready to take the next step in your career? Explore our job opportunities in the vibrant city of Oro Valley, Arizona! Nestled in the picturesque Sonoran Desert, Oro Valley offers a perfect blend of breathtaking natural beauty, a thriving job market, and a welcoming community. With its proximity to the stunning Catalina State Park for outdoor enthusiasts, renowned art galleries like the Etherton Gallery in nearby Tucson, and a vibrant culinary scene boasting local favorites like Sonoran hot dogs, Oro Valley is a hub of endless possibilities. Join us in this dynamic region, where growth opportunities abound and a unique blend of culture and charm awaits you. Discover your next career move in Oro Valley today!