Regulatory Affairs Specialist

Penumbra, Inc.

. Assist in preparing regulatory submissions, including 510(k), CE Mark Technical Documentation, UKCA Mark, regional Regulatory submissions, IDE, non-US Clinical Trial Submission, Shonin, and Certificates to Foreign Government .

Posted 9/16/2026full-timeAlameda • California • United StatesMid-LevelSenior💰 $77,000 - $98,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in preparing and managing regulatory submissions for medical devices, including 510(k) and CE Mark documentation, while ensuring compliance with Quality System regulations such as ISO 13485. Proficient in regulatory intelligence research and effective communication across various levels of an organization.

Highest-signal resume keywords

Regulatory Medical Device ExperienceQuality System Regulations (ISO 13485)Regulatory Submissions (510(k), CE Mark)Excellent Written and Oral Communication SkillsProficiency in Word, Excel, PowerPoint

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsRegulatory Intelligence ResearchQuality System RegulationsTechnical Standards ApplicationDocument PreparationLabeling ReviewRegulatory Change AssessmentProject TrackingSOP TrainingCompetitor Product Analysis

Soft Skills

Interpersonal CommunicationTeam CollaborationAttention to DetailAdaptabilityProblem-Solving

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft PowerPoint

Industry Keywords

510(k)CE MarkUKCA MarkIDENon-US Clinical Trial SubmissionShoninCertificates to Foreign GovernmentDesign ControlRegulatory AffairsMedical Device Regulations

About the role

Key responsibilities & impact

Assist in preparing regulatory submissions, including 510(k), CE Mark Technical Documentation, UKCA Mark, regional Regulatory submissions, IDE, non-US Clinical Trial Submission, Shonin, and Certificates to Foreign Government
Track multiple projects concurrently
Maintain submission and approval documentation according to internal procedures
Support in-country Regulatory Affairs personnel to facilitate global clearances and approvals
Research Regulatory Intelligence, including competitor product information and approvals and new or updated regulations/guidance
Support labeling reviews, including Instructions for Use and product labels
Train in existing systems, Work Instructions, and SOPs to support departmental functions and the Quality System
Support Regulatory change assessment for product changes
Coordinate, prepare, and maintain document packages for worldwide regulatory submissions

Requirements

What you’ll need

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
Understand Quality System regulations (ISO 13485), Design Control, and regional Regulatory requirements
Willingness and ability to work on site as needed
Ability to move between buildings and floors
Ability to remain stationary and use a computer or other standard office equipment for an extensive period each day
Ability to read, prepare emails, and produce documents and spreadsheets
Ability to move within the office and access file cabinets or supplies, as needed
Ability to communicate and exchange accurate information with employees at all levels on a daily basis

Benefits

Comp & perks

Medical, dental, vision, life, AD&D, short- and long-term disability insurance
401(k) with employer match
Paid parental leave
Eleven paid company holidays per year
Minimum of fifteen days of accrued vacation per year, increasing with tenure
Paid sick time in compliance with applicable law(s)
Competitive compensation package
Equity program, when applicable
Collaborative teamwork environment
Learning opportunities and performance rewards