Regulatory Affairs Specialist II

Penumbra • Alameda, CA

6d • $90,000 - $125,000 • Onsite

About The Position

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. You will be responsible for the coordination, preparation, and maintenance of document packages for worldwide regulatory submissions.

Requirements

• A Bachelor's degree in science discipline or related field with 2+ years of experience, or equivalent combination of education and experience
• Proven ability to use and apply technical standards, principles, theories, concepts, and techniques.
• Strong oral, written, and interpersonal communication skills
• High degree of accuracy and attention to detail
• Proficiency with MS Word, Excel, and PowerPoint
• Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously

Nice To Haves

• Regulatory Medical Device experience preferred

Responsibilities

• Under direct supervision, prepare moderately complex submissions to gain approvals for clinical research, export, and commercial distribution, such as: IDE, 510(k), CE-Mark Technical Dossier, UKCA Mark, other regional Regulatory submissions, non-US Clinical Trial Submission, Shonin, and Certificates to Foreign Government
• Track multiple projects concurrently
• Ensure that existing approvals and documentation are maintained
• Communicate with in-country RA personnel to facilitate global clearance/approvals
• Monitor, research, and obtain information on FDA clearances/approvals of competitors, and proactively share this information with interested parties
• Communicate with regulatory agencies under direct supervision
• Perform reviews with some oversight of design control documents (e.g., engineering protocols, reports, product drawings, etc.), quality system procedures relating to commercialization, labeling (e.g., Instructions for Use, product labels, promotional materials), and risk management to ensure regulatory compliance.
• Assist in performing moderately complex research to support strategic planning
• Analyze existing systems and procedures, recommend solutions/improvements, and write or revise Work Instructions and SOPs as needed 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 in activities (e.g., execution, documentation) related to Field Corrective Actions.

Benefits

• medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level