Regulatory Affairs Specialist IV, Medical Devices, Hybrid

Job overview

The Regulatory Affairs Specialist IV role is hybrid, with three onsite days per week, in Sunnyvale, California. Compensation is $55–$60 per hour depending on qualifications. The position is a six-month contract. System One provides outsourced services and workforce solutions across North America. The specialist leads regulatory strategy and submissions for medical devices across product development, design changes, lifecycle management, and approvals in the United States, Canada, and global markets. The role advises product teams, prepares submissions, coordinates agency responses, and aligns regulatory guidance across functions.

What you'll do

• Provide regulatory guidance and develop regulatory plans
• review design-control documentation
• determine regulatory pathways for U.S. and Canadian markets
• assess regulatory impacts of product and facility changes
• author and lead FDA 510(k), pre-submission, and Health Canada submissions
• coordinate responses to agency requests
• support global submissions and implementation.

What we're looking for

Skills & competencies

regulatory affairs specialist iv

medical devices

hybrid

sunnyvale ca

system one

$55–$60/hour

six-month contract

fda 510(k)

health canada

regulatory strategy

product lifecycle management

design controls

Work arrangement

• Weekend coverage required

Benefits & perks

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

Why this role

Hybrid schedule with three onsite days weekly; six-month contract; requires at least eight years of medical-device regulatory affairs experience.

About the employer

System One is hiring for this role. Industry: Employment Placement Agencies. Sector: 56.