Regulatory Affairs Specialist Job at Penumbra, Inc. | Apply Now
A rare chance to join Penumbra, Inc. as a Regulatory Affairs Specialist in Alameda, CA. This role focuses on worldwide medical device submissions, including 510(k), CE Mark, and UKCA, offering a competitive salary range of $77,000–$98,000 per year. Applications are open until the position is filled.
- Position: Regulatory Affairs Specialist I
- Location: Alameda, CA, United States
About Penumbra, Inc.
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. The organization designs, develops, manufactures, and markets novel products that address 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, along with distributors in select international markets.
Regulatory Affairs Specialist Job Description
In this Regulatory Affairs Specialist role, the selected candidate will work with the team that ensures that Penumbra products are approved for use in countries around the world, thereby helping to bring life-saving technologies to patients. Responsibilities include the coordination, preparation, and maintenance of document packages for worldwide regulatory submissions.
Eligibility Criteria
- A Bachelor’s degree in a relevant discipline or an equivalent combination of education and 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.
Regulatory Affairs Specialist Responsibilities
- Assist in preparing various submissions to gain approvals, such as 510(k), CE Mark Technical Documentation, UKCA Mark, and other regional regulatory submissions.
- Track multiple projects concurrently and 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.
- 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.
Salary: $77,000–$98,000 / year
Why Join Penumbra?
Penumbra offers a collaborative teamwork environment where learning is constant, and performance is rewarded. The opportunity to be part of a team that is revolutionizing the treatment of some of the world’s most devastating diseases is available, along with a generous benefits package for eligible employees.
This Regulatory Affairs Specialist position at Penumbra, Inc. represents an excellent opportunity for qualified candidates to contribute to innovative healthcare solutions. Interested individuals are encouraged to apply at the earliest opportunity.
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