Regulatory Affairs Specialist I

Penumbrainc; Alameda (CA); On-site; USD 77,000 - 98,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

AD&D

Disability insurance

401(k) with employer match

Paid parental leave

11 company holidays

Paid vacation

Paid sick time

Job summary

Penumbra, Inc. in Alameda, California seeks a Regulatory Submissions Coordinator to prepare and maintain document packages for worldwide regulatory submissions. The role supports 510(k), CE Mark, UKCA, IDE, and other regulatory processes.

Under supervision, you will assist with tracking multiple projects, ensure documentation aligns with internal procedures and Quality System, and help in-country RA personnel to facilitate global clearances. Occasional travel 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

• Assist in preparing submissions to gain approvals (510(k), CE, UKCA, IDE, non-US Clinical Trial Submission, Shonin, and Certificates to Foreign Government)
• Track multiple projects concurrently
• Maintain submission/approval documentation per internal procedures
• Support in-country RA personnel to facilitate global clearance/approvals
• Research Regulatory Intelligence (competitor info, regulations, guidance) as directed
• Support labeling reviews (Instructions for Use, product labels)
• Train in systems, Work Instructions, and SOPs to support the department and Quality System
• Understand ISO 13485, Design Control, and regional Regulatory requirements
• Support Regulatory change assessment for product changes

Skills

Regulatory medical device experience

Communication skills

MS Office

Technical standards

Regulatory submissions

Education

Bachelor's degree

Job description

In this role, you will work with the team that ensures that Penumbra products are approved for use in countries around the world, thereby helping to bring our life‑saving technologies to patients worldwide. You will be responsible for the coordination, preparation, and maintenance of document packages for worldwide regulatory submissions.

What You’ll Work On

• 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.

What You Contribute

• 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

Working Conditions

General office environment. Willingness and ability to work on site as needed. May have business travel from 0% - 30%. Must be able to move between buildings and floors. Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. Must be able to read, prepare emails, and produce documents and spreadsheets. Must be able to move within the office and access file cabinets or supplies, as needed. Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.

Annual Base Salary Range: $77,000 - $98,000 / year

We offer a competitive compensation package plus a benefits and equity program, when applicable.

Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

What We Offer

• A collaborative teamwork environment where learning is constant, and performance is rewarded.
• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
• A generous benefits package for eligible employees that includes 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, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.

If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.

For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.