Staff Regulatory Affairs Specialist

🔥 0 minutes ago

🏈 Alabama, Arizona, +32 more states – Remote

🏈 Alabama – Remote 🌵 Arizona – Remote 🏄 California – Remote ⛰️ Colorado – Remote 🦌 Connecticut – Remote 🐊 Florida – Remote 🥔 Idaho – Remote 🌽 Illinois – Remote 🌾 Iowa – Remote 🌪️ Kansas – Remote 🐎 Kentucky – Remote ⚜️ Louisiana – Remote 🦞 Maine – Remote 🦬 Montana – Remote 🌾 Nebraska – Remote 🎰 Nevada – Remote 🏖️ New Jersey – Remote 🏈 Ohio – Remote 🌪️ Oklahoma – Remote 🌲 Oregon – Remote 🦀 Maryland – Remote 🍂 Massachusetts – Remote 🚗 Michigan – Remote ❄️ Minnesota – Remote 🎸 Mississippi – Remote 🏰 Missouri – Remote 🔔 Pennsylvania – Remote 🎸 Tennessee – Remote 🤠 Texas – Remote ⛷️ Utah – Remote 🍁 Vermont – Remote ⚔️ Virginia – Remote ☕ Washington – Remote 🦬 Wyoming – Remote

💵 $135.5k - $216.8k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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BD

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1897

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

💰 $24M Grant on 2020-07

Healthcare • Manufacturing • Healthcare Insurance

BD (Becton, Dickinson and Company) is a global medical technology company dedicated to advancing the world of health. It focuses on developing innovative technologies, services, and solutions to improve safety and efficiency in healthcare. BD offers a wide range of products including medication management solutions, surgical solutions, cervical cancer screening, drug delivery systems, and laboratory services. The company is also involved in infection risk management and provides advanced clinical insights to enhance patient outcomes. With a commitment to global health sustainability and social investing, BD is a leader in healthcare technology and services worldwide.

📋 Description

• Coordinate, prepare, and complete premarket applications to the US FDA, including 510(k), Pre-Sub, and De Novo submissions • Act as liaison with FDA regarding product submissions • Assess whether proposed device modifications require a 510(k) application • Prepare non-filing justifications for changes that do not require a 510(k) submission • Coordinate and prepare technical files for European Notified Bodies for CE marking of new and modified products • Provide regulatory leadership and guidance to cross-functional product development teams • Identify and communicate quantified regulatory risks and mitigation approaches • Manage Notification of Change and International Regulatory Affairs assessments for sustaining activities • Develop regulatory strategies for Change Controls and establish Regulatory Requirements • Support global regulatory strategies and collaborate with international regulatory associates • Lead regulatory efforts for new regulations and international standards, including EU MDR/IVDR and MDSAP • Review and approve product labeling, promotional materials, and advertising materials • Coordinate responses to customer product-information requests and questionnaires • Maintain FDA device listings and facility registrations • Develop and maintain SOPs, work instructions, and policies • Represent BD in external trade organizations and support regulatory standards development and compliance activities • Improve the efficiency of current work processes

🎯 Requirements

• B.S. degree in a scientific, health sciences or technical discipline required (e.g., engineering, bioengineering, biology, chemistry) • 5 years of Regulatory Affairs experience in medical device or in vitro diagnostic device companies • Proficient in technical writing skills and compiling successful submissions for the appropriate audience • Experience maintaining confidentiality in dealing with regulatory and clinical documentation • Experience with cross-functional collaboration and teamwork skills including influencing without authority • Proficient in Microsoft Word, Excel, and PowerPoint

🏖️ Benefits

• Medical, dental, vision, health savings and flexible spending accounts • Life and disability insurance • Wellness resources • Mental health support and disease management programs • 401(k) • Deferred compensation programs • Financial counseling • DailyPay • Educational savings resources • Paid time off • Company holidays • Educational assistance • Parental leave • Adoption assistance • Backup care • Caregiving support • Employee assistance programs • Commuter benefits • Pet insurance • Legal services • Associate discount programs • Bereavement, military, personal, family and medical leave, and jury duty leave • Reward and recognition opportunities • Competitive compensation and benefits programs

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