What are the responsibilities and job description for the Regulatory Affairs Manager - PHCS position at System One?
Job Title: Regulatory Affairs Manager - PHCS
Location: Tucson, AZ
Type: Contract
Compensation: $45-55.00/hr
Work Model: Onsite – onsite
Hours: 40.0
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.
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 COMPANY 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.
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.
System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
#M- #LI- Ref: #568-Clinical
Salary : $45 - $55