Regulatory Affairs Specialist I — Global Submissions

Penumbra, Inc.; Roseville (CA); On-site; USD 77,000 - 98,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with employer match

Paid parental leave

Paid holidays and vacation

Job summary

Penumbra, Inc. seeks a Regulatory Submissions Associate to coordinate and maintain document packages for worldwide regulatory submissions. You will assist with 510(k), CE Mark Tech Doc, UKCA, IDE, and other submissions, under supervision.

You’ll track multiple projects, ensure documentation aligns with internal procedures, and support in-country RA staff to enable global approvals, while staying current on regulatory guidance.

Qualifications

• Bachelor’s degree in a relevant discipline or equivalent experience.
• Regulatory medical device experience preferred.
• Excellent written, oral, and interpersonal communication skills.

Responsibilities

• Assist in preparing submissions such as 510(k), CE Mark Tech Doc, UKCA, IDE, non-US submissions.
• Assist in tracking multiple projects concurrently.
• Maintain submission documentation per internal procedures.
• Support in-country RA personnel to facilitate global clearances/approvals.
• Research regulatory information and update on regulations/guidance.
• Support labeling reviews and training on systems and SOPs.

Skills

Regulatory submissions knowledge

Regulatory intelligence research

Excellent written, oral, interpersonal

Education

Bachelor’s degree in a relevant discipline

Tools

Word

Excel

PowerPoint

Job description

Penumbra, Inc. seeks a Regulatory Submissions Associate to coordinate and maintain document packages for worldwide regulatory submissions. You will assist with 510(k), CE Mark Tech Doc, UKCA, IDE, and other submissions, under supervision.

You’ll track multiple projects, ensure documentation aligns with internal procedures, and support in-country RA staff to enable global approvals, while staying current on regulatory guidance.