Uncubed
   

Regulatory Affairs Specialist

Penumbra, Alameda, CA

Innovative Medical Devices

Duration: Full-Time


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.

What you'll work on

  • Responsible for management of regulatory submissions and project timelines
  • Support the preparation of submissions to gain clearances/approvals for US, EU and Japan, clinical research, export, and commercial distribution around the world.
  • Ensure that existing clearances/approvals and documentation are maintained.
  • Communicate with health authorities and in-country Regulatory Affairs personnel to facilitate regulatory clearances and approvals.
  • Support the creation, translation and review of labeling, Instructions for Use, and promotional materials.
  • Track multiple Regulatory projects concurrently 
  • Analyze existing systems and procedures, recommending improvements as needed.
  • Support the development of Work Instructions and SOPs as needed to support departmental functions and the Quality System.
  • Demonstrates an understanding of the Quality System, biocompatibility requirements, Design Control, Medical Device Directive, Essential Requirements, Medical Device Regulation, General Safety And Performance Requirements, ISO 13485, labeling requirements, Quality System Regulation, FDA regulations, export requirements, and regulatory requirements of pertinent regions.

What you bring

  • Bachelor’s degree in a science discipline and 1+ year experience in a medical device company; or an equivalent combination of education and experience.
  • 1+ year of experience in regulatory affairs, quality assurance, clinical affairs or a related field, in the medical device space.
  • Demonstration of a keen attention to detail; ability to work independently and as part of a team.
  • Outstanding written, oral, and interpersonal communication skills.
  • The ability to succeed in a fast-paced atmosphere with a proven ability to be flexible and adaptable within a dynamic environment.
  • Proficient in Microsoft Word, Excel and Adobe Acrobat.

What we offer

  • A collaborative teamwork environment where learning is constant and performance is rewarded.
  • The opportunity to be at the forefront of technology that is revolutionizing the treatment of some of the world's most devastating diseases.
  • A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan.
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, disability or protected veteran status.

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 that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan

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, disability or protected veteran status.

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

About Penumbra

PENUMBRA TODAY Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on interventional therapies. Penumbra designs, develops, manufactures and markets innovative devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs across two major markets, neuro and peripheral vascular. Penumbra sells its products to hospitals 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.

Penumbra

Want to learn more about Penumbra? Visit Penumbra's website.