Job Description: SummaryThis position is responsible for the regulatory assessment for the product changes and preparation of regulatory submissions required to market medical devices in U.S, Europe and other international markets, and related regulatory affairs activities, addresses all regulatory requirements as well as the objectives of the business. Requires the analysis of data, problem solving analysis and in depth evaluations of various factors.
Dedicated regulatory support for BD's Cost Synergy program for WW Infusion Disposables. Work closely with various work streams to evaluate the regulatory impact to the proposed changes and provide strategic input to the team for decision making.
Manage the submissions both domestically and internationally for the projects.
Coordinate, prepare, and follow up with FDA Premarket Notification [510(k)] submissions in a timely manner. Act as liaison with FDA regarding product clearance.
Assess necessity for submitting a 510(k) application for proposed device changes.
Prepare internal "Non-Filing Justifications" (U.S.) for changes that do not require a 510(k) submission. Prepare technical files for CE marking with appropriate input/help from various functions (R&D, Quality, Manufacturing, etc.) in a timely manner.
Submit notification to the Notified Body about significant changes to CE marked products in a timely manner.
Reviews clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance.
Coordinate and collect specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments as necessary
Submit product listing to the FDA when deemed necessary. Support International Registrations as it relates to product changes and/or new product launches
Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies on an as-needed basis.
B.S. degree or higher in a technical discipline, preferably in computer science, engineering, bioengineering, biology, or chemistry
3-5 years Regulatory Affairs experience in medical device regulations
Demonstrated success in taking products through FDA and EU Notified Bodies.
International product registration experience preferred.
Working knowledge of 510(k), MDD 93/42/EEC.
Working knowledge of 21 CFR 820 -Quality System Regulation.
Working knowledge of standards and FDA guidances.
Proficient in using Microsoft Word, Access, Excel
Strong communication and project management skills.
Must be able to handle multiple tasks.
Attention to details.
This position is through 9/30/2020. This position works closely with the RA Leadership Team, and our hope is the candidate would find a long-term position within BDX.
Primary Work LocationUSA CA - San Diego Bldg A&B
Additional LocationsUSA CA Brea
BD (Becton, Dickinson And Company)