Job Description Summary # Job Description This position is responsible to support preparation of regulatory submissions required to market medical devices in an international community (including USA and EU), support international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as objectives of the business. Requires data analysis, problem solving, and attention to detail. The following items are to be carried out with minor supervision: + Provide support for FDA Premarket Notification [510(k)] submissions in a timely manner. + 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 from various functions (R&D, Quality, Manufacturing, etc.) in a timely manner. + Submit notifications to various geographies about significant changes to registered products in a timely manner, including 'non-filing' justifications to EU Notified Body. + Review/approve labeling to ensure regulatory compliance. + Support creation and revision of 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, new product launches, and/or product renewals Required Qualifications: + At least a B.S. degree, preferably in engineering, bioengineering, biology, or chemistry Preferred Qualifications: + At least 1 year of experience in medical device industry + Demonstrated success in taking products through FDA and EU Notified Bodies + Working knowledge of 510(k), MDD 93/42/EEC, MDR 2017/745 + Experience with vascular access devices Skills: + Proficient in using Microsoft Office + Strong communication and project management skills + Must be able to handle multiple tasks + Attention to detail + Ability to learn and grasp oftentimes complex concepts quickly Knowledge: + Some knowledge of 510(k), MDD 93/42/EEC, MDR 2017/745 is preferred + 21 CFR 820 - Quality System Regulation + Medical device standards and FDA guidance relevant to medical devices Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status. BD and Covid-19: To ensure the safety of our associates, BD supports remote work where possible. This position is based in the listed location but is temporarily remote-based due to Covid-19. Any offer of employment is contingent upon the candidate reporting to work at the site if/when associates are requested to return to the workplace. Local applicants are preferred; however, remote candidates will also be considered. # Primary Work LocationUSA UT - Salt Lake City BAS # Additional Locations # Work Shift Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.