What You'll Achieve
- Assist in preparing moderately complex submissions to gain approvals for clinical research, export, and commercial distribution, such as: IDE, non-US Clinical Trial Submission, 510(k), Shonin, PLA, CE-Mark Design Dossier, CE-Mark Technical Dossier, other Dossiers, and Certificates to Foreign Government.
- Ensure that existing approvals and documentation are maintained.
- 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 proactively share this information with interested parties.
- Support the creation, translation and review of labeling, Instructions for Use, and promotional materials.
- Analyze existing systems and procedures, recommending improvements as needed.
- Write or revise 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 or Master's degree in a science or engineering discipline such as biology, neuroscience, chemistry or biomedical engineering.
- At least five years of Regulatory Affairs experience in the medical device industry, or an equivalent combination of education and experience.
- Knowledge of domestic (FDA) and foreign regulatory requirements for the manufacture and distribution of medical devices.
- Experience with multiple regulatory submissions, including familiarity with Master Files, 510(k)s, or IDEs.
- 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 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.
Want to learn more about Penumbra? Visit Penumbra's website.
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