Regulatory Affairs Specialist I

Job overview

The Regulatory Affairs Specialist I role is onsite in Alameda, CA, with an annual base salary of $77,000–$98,000. Penumbra develops healthcare technologies intended to address challenging medical conditions and help patients worldwide. This role supports global product approvals by coordinating, preparing, and maintaining regulatory submission documents. Under direct supervision, the specialist assists with submissions, tracks projects, supports labeling reviews and regulatory change assessments, and helps maintain documentation in line with internal procedures and quality requirements.

What you'll do

• Assist with regulatory submissions, including 510(k), CE Mark, UKCA, regional submissions, IDE, non-US clinical trial submissions, Shonin, and Certificates to Foreign Government
• track concurrent projects
• maintain submission and approval documentation
• support in-country regulatory personnel, labeling reviews, regulatory intelligence research, and product-change assessments.

What we're looking for

Skills & competencies

regulatory affairs

medical devices

global regulatory submissions

510(k)

ce mark

ukca

quality system

iso 13485

alameda ca

penumbra

$77k-$98k/year

business travel 0%-30%

Work arrangement

• Weekend coverage required

Benefits & perks

• Medical, dental, vision, life, AD&D, short- and long-term disability insurance
• 401(k) employer match
• paid parental leave
• 11 paid company holidays
• at least 15 accrued vacation days, increasing with tenure
• paid sick time
• benefits and equity program when applicable.

Why this role

Supports regulatory approvals for life-saving medical technologies used worldwide; business travel may range from 0% to 30%.

About the employer

Penumbra is hiring for this role. Industry: Offices of Physicians (except Mental Health Specialists). Sector: 62.