Regulatory Affairs Manager – PHCS

Planet Pharma; Tucson (AZ); On-site; USD 55,000 - 76,000; Full time

Job summary

Planet Pharma is seeking a Regulatory Affairs lead focusing on software and instrument products. You will secure and maintain regulatory approvals, drive cross-functional collaboration, and oversee lifecycle management in a fast-paced medical device environment.

The role requires 3–5 years with a PhD or 5–7 years with a Master’s or 6–8 years with a Bachelor’s in IVDrs/Medical Devices/Pharma/Biopharmaceuticals, plus FDA submissions experience.

Qualifications

• 3–5 years experience with a PhD in IVDrs/Medical Devices/Pharma/Biopharmaceuticals.
• 5–7 years with a Master’s degree or 6–8 years with a Bachelor’s degree in the field with Regulatory Affairs experience.
• Regulatory experience with FDA submissions for software or instrumentation in medical devices.

Responsibilities

• Submission & Compliance: Oversee registration dossiers and global submission plans, manage the full product lifecycle.
• Regulatory Strategy: Develop strategies to accelerate global approvals and interpret health authority expectations.
• Stakeholder & External Engagement: Build relationships, negotiate outcomes, and manage audit preparations.
• Decision-Making & Problem-Solving: Identify risks and implement cost-effective solutions with proper delegation.
• Leadership & Team Culture: Mentor junior staff and drive adoption of new technologies.
• Communication: Clearly articulate complex ideas and build trust across teams.

Skills

Regulatory affairs

Stakeholder management

Communication

Project management

Leadership

Education

PhD

Master’s degree

Bachelor’s degree

Job description

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