P

Penumbra Inc

Neurovascular and peripheral medical devices manufacturer

Regulatory Affairs Specialist 2

Full-TimeUpdated on 10/23/2026
$90k - $125k/yr+ Equity program, when applicable
Junior
Bachelor's
Alameda, CA, USA
HybridHybrid work in Alameda; willingness to work on site and 10%–30% business travel.
Biology & BiotechRegulatory & Quality (Life Sciences)
Company Historically Provides H1B Sponsorship

About the job

Requirements
  • A bachelor's degree in a science discipline or related field, with 2+ years of experience, or an equivalent combination of education and experience.
  • Proven ability to use and apply technical standards, principles, theories, concepts, and techniques.
  • Proficiency with Microsoft Word, Excel, and PowerPoint.
  • Ability to prioritize assignments while handling various projects simultaneously.
  • Willingness and ability to work on site and travel for business 10%–30%.
  • Ability to work in general office and laboratory environments, including potential exposure to blood-borne pathogens.
  • Ability to move between buildings and floors, remain stationary and use standard office equipment for extended periods, access file cabinets or supplies, and read, prepare emails, and produce documents and spreadsheets.
Responsibilities
  • Prepare moderately complex regulatory submissions to gain approvals for clinical research, export, and commercial distribution, including IDE, 510(k), CE-Mark Technical Dossier, UKCA Mark, other regional regulatory submissions, non-US clinical trial submissions, Shonin, and Certificates to Foreign Government.
  • Track multiple projects concurrently.
  • Maintain existing approvals and documentation.
  • Communicate with in-country regulatory affairs personnel to facilitate global clearances and approvals.
  • Monitor, research, and obtain information on FDA clearances and approvals of competitors, and share this information with interested parties.
  • Communicate with regulatory agencies under direct supervision.
  • Review design control documents, quality system procedures relating to commercialization, labeling, and risk management to ensure regulatory compliance.
  • Assist with moderately complex research to support strategic planning.
  • Analyze existing systems and procedures, recommend improvements, and write or revise Work Instructions and SOPs to support departmental functions and the Quality System.
  • Understand the Quality System, biocompatibility requirements, Design Control, Medical Device Directive, Essential Requirements, ISO 13485, labeling requirements, Quality System Regulation, Canadian regulations, export requirements, and regulatory requirements of pertinent regions.
  • Assist with activities related to Field Corrective Actions, including execution and documentation.
  • Communicate and exchange accurate information with employees at all levels.
Desired Qualifications
  • Regulatory medical device experience.

About the company

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Penumbra Inc

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cbWebsite

Penumbra develops and sells medical devices for neurovascular and peripheral vascular conditions. Its products assist doctors in treating stroke and other vascular diseases by delivering—through systems like the Penumbra System and Indigo System—catheters, coils, and evacuation devices that are placed inside blood vessels. The company differentiates itself with a broad, integrated portfolio and a global sales network across Europe and the Americas, emphasizing engineering and clinical performance. Its goal is to improve patient outcomes and sustain growth by investing in ongoing research and development to expand its capabilities.

Company Size

1,001-5,000

Company Stage

IPO

Headquarters

Alameda, California

Founded

2004

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Simplify's Take

What believers are saying

  • Q2 2026 revenue reached $390.0 million, up 14.9%, with 67.9% gross margin.
  • September 9, 2026 Link launch expands Lightning Bolt workflows for resistant clot.
  • Magnendo's $18 million round, led by Penumbra, extends its stroke robotics ecosystem.

What critics are saying

  • June 3, 2026 RED 68 recall flags manufacturing defects and franchise reliability.
  • Incuvate sued Penumbra on August 19, 2026 over THUNDERBOLT patents; injunction risk.
  • Boston Scientific's acquisition still requires approvals; any 2026 slip derails employee retention and valuation.

What makes Penumbra Inc unique

  • Penumbra's CAVT platform pairs computer control with thrombectomy; THUNDERBOLT cleared FDA in 2026.
  • Broad neurovascular and peripheral portfolios sell into over 100 countries.
  • Deep physician evidence engine adds leaders like Donald Frei and published stroke studies.

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Benefits

  • Health Insurance
  • Dental Insurance
  • Vision Insurance
  • Life Insurance
  • Disability Insurance
  • 401(k) Retirement Plan
  • 401(k) Company Match
  • Paid Parental Leave
  • Paid Vacation
  • Paid Sick Leave
  • Paid Holidays

Growth & Insights and Company News

6 month growth

0%

1 year growth

0%

2 year growth

0%
Citybiz
Oct 15th, 2026
Vesalio appoints Daniel Davis to board to advance vascular device growth.

Vesalio appoints Daniel Davis to board to advance vascular device growth. October 15, 2026 Daniel Davis Vesalio, a privately held medical device company specializing in vascular intervention, has appointed Daniel Davis to its Board of Directors and as Advisor to the CEO, adding an executive with more than 25 years of medical technology experience as the company expands its thrombectomy business across coronary, peripheral vascular and neurovascular markets. Davis, a former senior executive at Penumbra and Imperative Care, will advise Vesalio on product portfolio strategy, commercialization and organizational growth. His appointment follows the publication of clinical data from the company's NATURE randomized controlled trial evaluating its enVast coronary thrombectomy technology. The leadership addition comes as Vesalio seeks to translate clinical research into broader commercial opportunities for its clot-removal technologies, which are designed to restore blood flow in patients with thromboembolic vascular disease. Davis brings experience developing medical device businesses from their early stages through large-scale commercial operations, including leadership roles spanning product development, corporate strategy and sales. At Imperative Care, he served in several senior positions, including President, Chief Operating Officer and Chief Strategy Officer. During his tenure, he helped develop the company's stroke treatment business and supported its expansion into vascular thrombectomy and Telos, a robotic-enabled remote stroke intervention business. Previously, Davis served as President and Chief Commercial Officer at Penumbra, where he joined the company in 2007 during its startup phase. He helped guide the business through its initial public offering and held responsibility for strategy and commercial operations across neurovascular, coronary and peripheral vascular technologies. His experience at both companies provides Vesalio with leadership expertise in markets where physician adoption, clinical evidence and procedural efficiency play important roles in medical device commercialization. "Daniel brings a proven record of building businesses from the early stage through initial public offering, shaping the product and commercial strategies that turn early clinical experience into market leadership," said Steve Rybka, CEO of Vesalio. Rybka said Davis's appointment comes at an important stage for the company following results from the NATURE trial involving its enVast coronary thrombectomy technology. The company has described the trial results as positive, although the announcement did not provide specific efficacy or safety outcomes. The NATURE study represents an important component of Vesalio's strategy in coronary thrombectomy, a procedure intended to remove blood clots from coronary arteries. The company is also developing its presence in neurovascular and peripheral vascular intervention, where thrombectomy devices are used to address blood clots affecting the brain and other parts of the circulatory system. These markets involve different clinical settings and procedural requirements, making product specialization and physician collaboration important considerations for manufacturers seeking to expand across multiple vascular treatment categories. For Vesalio, Davis's appointment brings commercial and operational experience across all three segments, potentially helping the company prioritize investments and coordinate product development with market expansion. "Vesalio is tackling critical unmet clinical needs across coronary, neurovascular, and peripheral thrombectomy," Davis said. "The recently published NATURE RCT marks a pivotal moment for the company and a catalyst for its next phase of growth." Davis said he plans to work with Rybka and the board to establish commercial priorities, refine the company's thrombectomy platforms and improve procedural workflows through collaboration with physicians. His dual role as director and CEO advisor places him in both the company's strategic oversight and executive advisory functions. That structure gives Vesalio access to his experience in scaling medical technology organizations while developing product strategies suited to different vascular intervention markets. Vesalio's proprietary technologies are designed to remove different types of blood clots and restore circulation to ischemic tissue in the heart, brain and peripheral vasculature. According to the company, its products have been used to treat more than 20,000 patients across more than 60 countries, providing an established international base for further commercial development. The appointment also reflects the importance of experienced medical device leadership as companies seek to build on clinical evidence and expand physician adoption. Bringing new technologies into routine clinical practice requires coordination among product development, clinical research, regulatory activities and commercial execution. For Vesalio, the next phase of development will center on advancing its thrombectomy portfolio and expanding its commercial presence while building on the clinical work supporting its coronary technology. Davis's addition to the board provides the company with an executive who has previously managed growth across the same vascular intervention categories, strengthening its leadership as it pursues broader adoption of its clot-removal devices.

Business Insider
Oct 2nd, 2026
RBC Capital keeps their Hold rating on Penumbra (PEN).

RBC Capital keeps their Hold rating on Penumbra (PEN). Oct. 2, 2026, 09:47 PM In a report released on October 1, Kendall Au from RBC Capital maintained a Hold rating on Penumbra, with a price target of $374.00. The company's shares closed yesterday at $318.00. According to TipRanks, Au is an analyst with an average return of -3.6% and a 22.22% success rate. Au covers the Healthcare sector, focusing on stocks such as Becton Dickinson, GE Healthcare Technologies Inc, and Boston Scientific. Penumbra has an analyst consensus of Hold, with a price target consensus of $358.40. Based on Penumbra's latest earnings release for the quarter ending June 30, the company reported a quarterly revenue of $390.05 million and a net profit of $34.81 million. In comparison, last year the company earned a revenue of $339.46 million and had a net profit of $45.27 million Read More on PEN:

Penumbra, Inc.
Sep 9th, 2026
Penumbra launches Link, expanding vascular thrombectomy options for physicians.

Penumbra launches Link, expanding vascular thrombectomy options for physicians. September 9, 2026 Penumbra recently launched the Link(TM) clot capture device designed to support the removal of arterial thrombus when used in conjunction with Lightning Bolt(R) technology. Link is designed to lock and hold clot, connecting to the power of computer assisted vacuum thrombectomy (CAVT(R) to secure and maximize clot extraction. "Link expands the toolkit available to physicians by providing an additional mechanical clot engagement option that can help address resistant thrombus while maintaining aspiration with CAVT," said James F. Benenati, MD, FSIR, chief medical officer at Penumbra. "By offering clinicians greater flexibility in challenging cases, it has the potential to improve procedural efficiency and support more effective patient care." Deployed into thrombus, Link engages and mobilizes organized clot while aspiration facilitates clot ingestion into the aspiration catheter. Designed to complement existing Lightning Bolt workflows, Link can be incorporated when additional mechanical clot engagement is desired, without requiring a fundamentally different procedural approach. Early physician experience has highlighted Link's ability to work synergistically with Lightning Bolt technology. "Link appeared to provide a secure hold on the embolus, allowing Bolt to more effectively aspirate the residual thrombus," said Thomas Heafner, MD, after using Link with Bolt 7. "Combining Link with Lightning Bolt resulted in rapid and effective clot clearance." "Link represents an important advancement in our CAVT portfolio, providing an additional option for engaging and removing challenging blood clots," said Shruthi Narayan, president of Penumbra. "Link was designed to bring a new dimension to thrombectomy by combining secure clot engagement with the power of modulated aspiration, offering clinicians an additional therapeutic option for some of the most challenging cases. This launch reflects our continued commitment to developing technologies that advance vascular care and improve patient outcomes." Designed to Secure Clot and Maximize Extraction LINK is designed to lock and hold clot while leveraging the power of CAVT to support clot removal. Its unique architecture is engineered to minimize vessel wall engagement and support atraumatic clot extraction. Important Safety Information Additional information about Penumbra's products can be located on Penumbra's website at https://www.penumbrainc.com/products/peripheral-thrombectomy-cavt/. The clinical results presented herein are for informational purposes only and may not be predictive for all patients. Individual results may vary depending on patient-specific attributes and other factors. Caution: Federal (USA) law restrictions these devices to sale by or on the order of a physician. Prior to use, please refer to the Instructions for Use (IFU) for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. For the complete Penumbra IFU Risk Summary Statements, visit: peninc.info/risk. Please contact your local Penumbra representative for more information.

GlobeNewswire
Aug 25th, 2026
Incuvate files patent infringement lawsuit against Penumbra.

Incuvate files patent infringement lawsuit against Penumbra. Complaint alleges Penumbra's THUNDERBOLT(TM) system infringes five Incuvate patents covering blood-clot detection technology. August 25, 2026 15:28 ET | Source: Incuvate LLC IRVINE, Calif., Aug. 25, 2026 (GLOBE NEWSWIRE) - Incuvate, LLC today announced that it has filed a patent-infringement lawsuit against Penumbra, Inc. in the U.S. District Court for the Northern District of California. The lawsuit, filed August 19, 2026, alleges that Penumbra's recently launched THUNDERBOLT(TM) Neurovascular Thrombectomy System and related components infringe five Incuvate patents directed to real-time aspiration monitoring technology used in catheter-based thrombectomy procedures. Incuvate's patents cover technology that uses pressure sensors, microprocessors, and pre-set pressure thresholds or differentials to provide real-time visual and audible feedback during aspiration procedures. Incuvate alleges that this technology helps distinguish between clot engagement and blood flow and provides clinicians with valuable information during thrombectomy procedures. The complaint identifies Penumbra's THUNDERBOLT system, Penumbra ENGINE vacuum source, THUNDERBOLT tubing and module, and associated RED Reperfusion Catheters as accused products. Incuvate alleges that these products use patented technology to detect flow conditions, including the presence of clot, and provide users with feedback regarding flow status. Through this lawsuit, Incuvate seeks to hold Penumbra accountable for what Incuvate alleges is Penumbra's unauthorized and willful infringement of the technologies embodied in the asserted patents. Incuvate is seeking damages, injunctive relief, and other remedies described in the complaint. A copy of the complaint is available through PACER Monitor in Incuvate, LLC v. Penumbra, Inc., Case No. 4:26-cv-08658. About Incuvate Incuvate works with medical device entrepreneurs to develop early-stage concepts into innovative products and leads them to market via new companies it finances, builds, and manages. Learn more at incuvatellc.com Media Contact Lance Capel Director of Strategy & External Relations [email protected]

Penumbra, Inc.
Aug 10th, 2026
Dr. Donald Frei joins Penumbra as Associate Chief Medical Officer of Neuro.

Dr. Donald Frei joins Penumbra as Associate Chief Medical Officer of Neuro. August 10, 2026 Penumbra announced today that Donald Frei, MD, FSNIS, FACR, will serve as Associate Chief Medical Officer of Neuro. A nationally recognized neurointerventional surgeon, Dr. Frei brings clinical and research expertise in stroke and neurovascular care to Penumbra's clinical leadership team. Reporting to James Benenati, MD, FSIR, Chief Medical Officer of Penumbra, Dr. Frei will help guide Penumbra's neurovascular clinical strategy, support evidence development, and collaborate with physicians worldwide to advance patient care. "Dr. Frei has dedicated his career to advancing neurovascular care, from pioneering faster stroke recanalization protocols to helping establish the clinical evidence behind therapies that improve patient outcomes," said Dr. Benenati. "His deep clinical expertise, commitment to innovation, and passion for patient care will be invaluable as we continue to expand the impact of our neurovascular technologies around the world." Throughout his career, Dr. Frei has authored more than 200 peer-reviewed publications and contributed to the advancement of neurovascular therapies through extensive clinical research and evidence generation. Recently, Dr. Frei was the co-principal investigator of the THUNDER Study, which demonstrated that Penumbra's CAVT(TM)(Computer Assisted Vacuum Thrombectomy) platform with THUNDERBOLT technology is safe and effective, paving the way for FDA clearance and CE Mark. Dr. Frei was also instrumental in launching the Get Ahead of Stroke(R) campaign to improve stroke triage and expand access to life-saving neuroendovascular care. "With the recent launch of CAVT with THUNDERBOLT, the neurovascular space is prime for transformation," said Dr. Frei. "I look forward to this opportunity to help advance innovation, generate evidence, deepen trust and closer collaboration with our medical and professional societies, and improve access to care so more patients are able to benefit from the latest technology." Dr. Frei is a leading board-certified neurointerventional surgeon and is a past president of the Society of NeuroInterventional Surgery. He earned his medical degree from the University of Cincinnati College of Medicine and completed his residency training in diagnostic radiology at Tulane University Medical Center. He subsequently completed fellowship training in neuroradiology and endovascular surgical neuroradiology at Washington University's Mallinckrodt Institute of Radiology. He has been recognized as a Fellow of the Society of NeuroInterventional Surgery (FSNIS) and a Fellow of the American College of Radiology (FACR).