This position is responsible for the preparation of regulatory submissions required to market new or modified medical devices in the U.S., Europe, and internationally and related regulatory affairs activities, such as development, execution and management of procedures and systems designed to ensure that the product development process, including clinical studies, 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. May provide leadership by assigning work and resolving complex problems.
The following items are to be carried out with minimal supervision.
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.
Review/approve labeling, promotional and advertising materials to ensure regulatory compliance.
Reviews clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance.
Represent RA in product life cycle development teams by reviewing, approving, and completing requirements.
Coordinate and collect specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments as necessary.
Represent RA in design teams and projects by providing regulatory guidance throughout the product development cycle and coordinating team inputs for regulatory submissions.
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 life science or technical discipline, preferably in engineering, bioengineering, biology, or chemistry
3-5 years Medical Device experience required
Working knowledge of industry consensus standards and FDA guidance
At least 2-4 years Regulatory Affairs experience in Medical Device regulations
Demonstrated success in taking products through FDA and EU Notified Bodies
Working knowledge of 510(k), MDD 93/42/EEC
Regulatory Affairs Certified RAC (RAPS)
Proficient in using Microsoft Office
Strong communication and project management skills
Must be able to handle multiple tasks
Attention to detail
510(k), MDD 93/42/EEC
21 CFR 820 - Quality System Regulation
Medical device standards and FDA guidance relevant to medical devices.
Employer will assist with relocation costs.
Internal Number: R-336940
About Becton Dickinson
BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We lead in patient and healthcare worker safety, and technologies that enable medical research and clinical laboratories. Our innovative solutions help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes.
BD partners with organizations around the world to address some of the most challenging global health issues. Our nearly 50,000 associates across 50 countries closely collaborate with customers and partners to help enhance patient outcomes, lower healthcare delivery costs, increase operational efficiencies and expand access to healthcare.
Our state-of-the-art facilities around the globe provide an environment that enables our highly talented and passionate workforce to be the best at their professions. We are always seeking great people to join our company on its journey to greatness.