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BD (Becton, Dickinson and Company) Regulatory Affairs Specialist I in Salt Lake City, Utah

Job Description Summary # Job Description This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business. Requires data analysis, problem solving, and attention to detail. + ### Represent RA on project teams by providing regulatory guidance throughout the product development cycle, coordinate team inputs for regulatory submissions, and review and approve applicable design control documentation. + ### Support International Product Registrations, including new registrations, re-registrations, and product changeregistrations/notifications. + ### Coordinate and collect specific registration information with R&D, Quality, Medical, Manufacturing, etc. + ### 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. + ### Support senior Regulatory personnel in preparing Premarket Notification [510(k)] submissions, as needed. + ### Prepare/update technical files for CE marking with appropriate input from various functions (R&D, Quality, Medical, Manufacturing, etc.). + ### Submit notifications to the EU Notified Body for significant changes to CE marked products. + ### Maintain Regulatory documentation. + ### Support special projects, as needed. Minimum Qualifications: This position requires: + ### Bachelors Degree in Life or Engineering Science, Business, or equivalency. + ### 0-2 years previous regulatory experience is preferred. + ### Good writing and strong organizational skills required. + ### Demonstrated communication and human relation skills. ​ Knowledge & Skills: + ### Ability to plan and schedule multiple priorities in a concurrent fashion. + ### Ability to review, collate and summarize scientific and technical data. + ### Excellent problem solving and analytical skills. + ### Good written and oral communication skills. + ### Ability to work well within cross-functional teams. + ### Complete work with minimal supervision and ability to work independently. # Why join us? A career at BD means that you are part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here you can fulfill your life’s purpose through the work that you do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates. ## To learn more about BD visit https://jobs.bd.com/ Becton, Dickinson and Company is an EqualOpportunity/AffirmativeAction 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. Becton, Dickinson and Company is an EqualOpportunity/AffirmativeAction 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. #LI-PRO # 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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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