Regulatory Affairs Manager — PHCS

Job overview

The Regulatory Affairs Manager — PHCS role is onsite in Tucson, AZ. Pay is $45–$55 per hour. The position supports the Regulatory Affairs team in securing and maintaining approvals for software and instrument products. The manager leads regulatory submissions and product lifecycle compliance, develops strategies for global approvals, engages internal and external stakeholders, and mentors staff while supporting effective, compliant product development.

What you'll do

• Oversee registration dossiers and global submission plans
• manage product lifecycle compliance and change controls
• develop strategies to accelerate global approvals
• interpret health authority expectations
• manage audit preparation and external engagement
• identify risks and solutions
• mentor junior staff and promote data stewardship and technology adoption.

What we're looking for

Skills & competencies

regulatory affairs manager

phcs

tucson az

$45–$55/hr

system one

regulatory submissions

medical devices

ivd

fda submissions

product lifecycle

global approvals

40 hours

Work arrangement

• Weekend coverage required

Benefits & perks

• Eligible employees may access medical, dental, vision, spending accounts, life insurance, voluntary plans, and a 401(k) plan.

Why this role

The posting specifies 40 hours onsite and seeks regulatory experience in medical devices, IVDs, pharmaceuticals, or biopharmaceuticals, including FDA submissions for software or instrumentation.

About the employer

System One is hiring for this role. Industry: Temporary Help Services. Sector: 56.