Regulatory Affairs Specialist III/Sr.

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about 1 year old

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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 Canada, 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 minimum 3+ years’ experience in Regulatory Affairs within a medical device company; or an equivalent combination of education and experience.
  • Minimum 2+ years’ experience preparing US 510ks and EU MDD and/or MDR submissions.
  • Working knowledge of EU MDR, Health Canada, and other submissions required.
  • Experience in providing Regulatory support on cross-functional teams for new product development and post market changes.
  • 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 perform in a fast-paced environment with a proven ability to be flexible and adaptable.
  • Proficient in Microsoft Word, Excel, SharePoint, and Adobe Acrobat. Basic knowledge in SAP. 

  • 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.