Regulatory Specialist

Alameda, CA
Regulatory Affairs
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

    • Support the preparation of submissions to gain approvals for clinical research, export, and commercial distribution around the world.
    • Ensure that existing approvals and documentation are maintained.
    • Communicate with in-country Regulatory Affairs personnel to facilitate global clearances and approvals.
    • Support the creation, translation and review of labeling, Instructions for Use, and promotional materials.
    • 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.
    • Develop a working understanding of 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.

What you bring

    • A Bachelor’s degree in a science or engineering discipline such as biology, neuroscience, chemistry or biomedical engineering.
    • One year of experience in regulatory affairs, quality assurance, clinical affairs or a related field, preferably in the medical device or biotechnology industry.
    • A keen attention to detail; ability to work independently and as part of a team.
    • Outstanding written, oral, and interpersonal communication skills.

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 medical devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs. Penumbra sells its products to hospitals and clinics 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 P 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.