Regulatory Affairs Manager - PHCS # 26-22099

Duration: 12 months (possible extension)

Description:
This is an onsite position for an experienced Regulatory Affairs Manager supporting Software and Hardware for PHCS (Personalized Healthcare Solutions).

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.

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’s 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.

About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring.



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