Regulatory Affairs Manager – PHCS

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 the companies 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.

Candidate Requirements

• 3-5 years experience with a PhD degree; 5-7 with Master’sdegree or 6-8 years with Bachelor’s degree in the field ofIVDs/Medical Devices/Pharma/Biopharmaceutical withsignificant 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 otherinternational regulations and demonstrated ability toadequately interpret and implement quality standardsconsidered an advantage.

Pay ranges between 40-55/hr based on experience