Position Details: Regulatory Affairs Manager – PHCS Location: Tucson AZ 85755 Pay Rate: Up to $45-55/Hr. on W2 Duration: 12+ months (extension possibility)
Regulatory Affairs Manager – Software & Hardware: This is an onsite position for an experienced Regulatory Affairs Manager supporting Software and Hardware for PHCS (Personalized Healthcare Solutions).
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.
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.
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.
Numbers & Facts
Location
Tucson, AZ
Salary
$45–$55 Per Hour
Skills
Auditingunmatched
Biotech and Pharmaceuticalunmatched
Change Controlunmatched
Communication Skillsunmatched
Cross-Functionalunmatched
FDA Requirementsunmatched
Hardware Administrationunmatched
Healthcareunmatched
Interpret Regulationsunmatched
Leadershipunmatched
Maintain Complianceunmatched
Medical Equipmentunmatched
Medical Instrumentationunmatched
Mentoringunmatched
Negotiation Skillsunmatched
Problem Solving Skillsunmatched
Product Lifecycle Managementunmatched
Productivity Managementunmatched
Quality Metricsunmatched
Regulationsunmatched
Risk Analysisunmatched
Software Administrationunmatched
Stewardshipunmatched
Strategic Planningunmatched
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