Global Regulatory Affairs Specialist II

Penumbra, Inc.; Alameda (CA); On-site; USD 90,000 - 125,000; Full time

Benefits offered by this job

Competitive benefits package

11 paid company holidays per year

Paid vacation time and sick time

Job summary

Penumbra, Inc. is seeking a Regulatory Associate to prepare and maintain documentation for worldwide regulatory submissions, ensuring approvals across regions. You will coordinate between teams and regulatory agencies to support clinical research, export, and commercial distribution.

The role requires a science degree with 2+ years of regulatory experience, strong communication skills, and proficiency with MS Word/Excel/PowerPoint. On-site work in Alameda, CA with travel likely.

Qualifications

• Bachelor's degree in science discipline or related field with 2+ years of experience.
• Regulatory Medical Device experience preferred.
• Strong written, oral, and interpersonal communication skills.

Responsibilities

• Prepare moderately complex submissions to gain approvals for regulatory submissions.
• Track multiple projects concurrently and maintain documentation.
• Communicate with in-country RA personnel to facilitate global clearance/approvals.
• Review design control documents, quality system procedures, labeling, and risk management for regulatory compliance.

Skills

Technical standards

Regulatory communication

Attention to detail

MS Office

Organization

Education

Bachelor's degree in science or related field

Tools

MS Word

Excel

PowerPoint

Job description

Penumbra, Inc. is seeking a Regulatory Associate to prepare and maintain documentation for worldwide regulatory submissions, ensuring approvals across regions. You will coordinate between teams and regulatory agencies to support clinical research, export, and commercial distribution.

The role requires a science degree with 2+ years of regulatory experience, strong communication skills, and proficiency with MS Word/Excel/PowerPoint. On-site work in Alameda, CA with travel likely.