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Sr. Regulatory Affairs Specialist (Remote)

Company: Becton Dickinson
Location: Tempe
Posted on: June 25, 2022

Job Description:

Responsibilities Job Description Summary Job Description Be part of something bigger BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues. The Sr. Regulatory Affairs Specialist is responsible for the preparation and documentation of regulatory submissions to government agencies. This includes activities such as preparation of clearance/approval/registration/licensure documentation for regulatory submissions to government agencies (worldwide), performing tasks associated with obtaining and maintaining product clearances licenses and registrations, and leading pre-market activities. Normally receives no instructions on routine work, general instructions on new assignments. May provide leadership by assigning work and resolving complex problems. The Sr. RA Specialist works on problems of high complexity and diverse scope, in which data analysis requires evaluation of identifiable factors. This position is a limited term assignment which will include benefits such as (medical, health, dental, 401k). Eligibility for these benefits will be based on the eligibility requirements as determined by the BD Total Rewards policy, and is anticipated to last approximately through May 31, 2024. Essential / Key Job Responsibilities (including supervisory and/or fiscal): Participates in EU MDR remediation activities as required to ensure that the product is in compliance with all internal and external regulatory requirements. Develops, documents and implements a regulatory submissions plan. Prepares and updates EU MDR Technical Documentation.Prepares U.S. FDA 510(k), IDE, PMA, submissions as required. Ensure that all submissions are accurate and completed in a timely manner, and that all arguments presented in the submission are appropriate, defendable, and scientifically based. Reviews Engineering Change Orders, Design Change Notices and other deviations for compliance with FDA, European and international regulations and standards. Represents BDPI in corporate/segment working groups. Ensures adequate documentation of compliance. Ensures continuous update and maintenance of the Regulatory Affairs files. Maintains regulatory databases/systems for key regulatory data (e.g. regulatory body communications, approvals, submission timelines) Assists in the claims development process and in qualifying support for key claims.Understands labeling global regulatory requirements. Understands the key business driver goals and aligns individual goals. Develops working relationships with key personnel/representatives of the U.S. FDA, EU notified bodies and international regions. Required Qualifications: Knowledge of U.S. and/or European and international regulations and standards covering medical devices. Ability to plan and schedule multiple priorities in a concurrent fashion. Ability to review, collate and summarize scientific and technical data. Ability to handle master documents, drawings, and specifications with a high degree of confidentiality. Excellent problem solving and analytical skills. Good written and oral communication skills. Detail-oriented, methodical and able to handle regulatory information and submissions. with a high degree of accuracy. Complete work with minimal supervision and ability to work independently. Knowledge of federal medical device regulations. This position also requires excellent writing and strong organizational skills. Preferred Qualifications RAC Certification Experience with EU MDR regulation Education and/or Experience Bachelor's degree or advanced degree in technical area such as biology, chemistry, engineering or medical-related field. Minimum of 3 years of RA related experience. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why join us? A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life's purpose through the work that they 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 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. PDN LI-PRO EU MDR Primary Work LocationUSA AZ - Tempe Headquarters Additional Locations Work Shift Apply Save Job PDN-96490354-247f-452f-8c9a-1a269629d47f

Keywords: Becton Dickinson, Tempe , Sr. Regulatory Affairs Specialist (Remote), Other , Tempe, Arizona

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