Regulatory Affairs Associate II — Medical Devices

Us Tech Solutions; Irvine (CA); On-site; USD 100,000 - 170,000; Full time

Job summary

US Tech Solutions, Irvine, CA, seeks a Regulatory Affairs professional to lead device regulatory strategies and submissions across global markets. You will collaborate with RA, R&D, and Operations to ensure timely approvals and lifecycle management for Class IIb devices.

Responsibilities include preparing submissions (INDs/CTAs), managing government interactions, and reviewing engineering/validation protocols, with focus on EU MDR 2017/745 requirements and cross-regional variations.

Qualifications

• 3–5 years of direct experience in device regulatory affairs.
• Experience supporting submissions and renewals outside US regions (JAPAC, MEAR, LATAM).
• Experience with Class IIb EU medical devices and EU MDR 2017/745.

Responsibilities

• Prepare device regulatory strategies and content for submissions (INDs/CTAs, amendments, new market applications).
• Engage RA, Operations, and R&D teams to align regulatory plans.
• File applications and manage government interactions for regulatory approvals.
• Review engineering and validation study protocols and approve manufacturing changes for Class IIb EU devices.

Skills

Regulatory strategy

Regulatory submissions

EU MDR knowledge

Lifecycle management

Cross-functional coordination

Education

Advanced degree

Job description

US Tech Solutions, Irvine, CA, seeks a Regulatory Affairs professional to lead device regulatory strategies and submissions across global markets. You will collaborate with RA, R&D, and Operations to ensure timely approvals and lifecycle management for Class IIb devices.

Responsibilities include preparing submissions (INDs/CTAs), managing government interactions, and reviewing engineering/validation protocols, with focus on EU MDR 2017/745 requirements and cross-regional variations.