Global Regulatory Submissions Specialist I

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

Benefits offered by this job

Collaborative culture

Impactful work

Comprehensive benefits

Job summary

Penumbra, Inc. in Alameda, CA seeks a Regulatory Affairs coordinator to help bring life-saving technologies to patients worldwide by preparing and maintaining document packages for regulatory submissions.

You will assist in preparing submissions (510(k), CE/UKCA, IDE, non-US trials, and foreign registrations), track multiple projects, and ensure documentation adheres to internal procedures and ISO 13485. Some travel (0–30%) may be required.

Qualifications

• A Bachelor’s degree in a relevant discipline or an equivalent combination of education and or demonstrated experience
• Regulatory Medical Device experience preferred
• Proven ability to use and apply technical standards, principles, theories, concepts, and techniques
• Excellent written, oral, and interpersonal communication skills
• Proficiency in Word, Excel, PowerPoint and other computer tools

Responsibilities

• Under direct supervision, assist in preparing various submissions to gain approvals, such as 510(k), CE Mark Technical Documentation, UKCA Mark, other regional Regulatory submissions, IDE, non-US Clinical Trial Submission, Shonin, and Certificates to Foreign Government
• Assist in the tracking of multiple projects concurrently
• Ensure that submission/approval documentation is maintained per internal procedures
• Support in-country RA personnel to facilitate global clearance/approvals.
• Research and obtain information on Regulatory Intelligence such as competitor product information and approvals, new or updated regulations/guidance, as directed.
• Support labeling reviews (e.g., Instructions for Use and product labels).
• Train in existing systems, Work Instructions, and SOPs as needed to support departmental functions and the Quality System.
• Understand Quality System regulations (ISO 13485), Design Control, and regional Regulatory requirements
• Support Regulatory change assessment for product changes.

Skills

Regulatory knowledge

Communication skills

Attention to detail

Team collaboration

Education

Bachelor's degree in relevant discipline

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Penumbra, Inc. in Alameda, CA seeks a Regulatory Affairs coordinator to help bring life-saving technologies to patients worldwide by preparing and maintaining document packages for regulatory submissions.

You will assist in preparing submissions (510(k), CE/UKCA, IDE, non-US trials, and foreign registrations), track multiple projects, and ensure documentation adheres to internal procedures and ISO 13485. Some travel (0–30%) may be required.