Regulatory Affairs Specialist – Innovation

🔥 0 minutes ago

🦀 Maryland – Remote

🦀 Maryland – Remote

💵 $95.9k - $153.4k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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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

• Provide regulatory guidance to new product development teams for in vitro diagnostic devices, automated laboratory systems, and related software products • Develop regulatory strategies and conduct risk assessments • Serve as Regulatory Affairs subject matter expert on new product development teams • Work cross-functionally with R&D, Medical Affairs, Quality, Marketing, Program Management, and other functions • Recognize and address potential regulatory risks in project plans • Organize and lead FDA and EU IVDR submissions • Prepare FDA submissions including Pre-IDEs, PMA, PMA Supplements, De Novo Petitions, 510(k) submissions, and CLIA Waiver applications • Prepare EU IVDR Technical Files/Dossiers • Serve as contact for FDA and Notified Body review teams during submission reviews and communications • Identify and propose continuous process improvements

🎯 Requirements

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, Pharmacy, or related scientific/technical discipline • 2–5 years of directly related regulatory experience in in vitro diagnostic devices and/or medical devices • Relevant experience in IVDs, medical devices, laboratory systems, or related regulatory healthcare technologies may be considered • Experience interpreting subjective and complex regulatory requirements • Understanding of advanced technical/scientific principles across diverse or complex product lines or manufacturing processes • Experience supporting product development and product support projects • Experience preparing, filing, and/or completing regulatory submissions, preferably as primary author • Ability to analyze complex issues and formulate sound approaches • Ability to exercise independent judgment and discretion • Ability to handle multiple tasks and prioritize and schedule work with minimal supervision • Experience coordinating cross-functional inputs from R&D, Quality, Medical Affairs, Program Management, and Marketing • Ability to compile and review documentation for FDA submissions and EU IVDR documentation • Understanding of regulatory submission processes and lifecycle management • Strong written and verbal communication skills • Experience working with cross-functional, fast-moving teams • Familiarity with SOPs, regulatory procedures, and quality systems such as ISO 13485 • Strong organizational skills and ability to manage multiple submissions/projects simultaneously • Adaptability to changing timelines and priorities • Proficiency in Microsoft Office tools, including Excel, Word, and PowerPoint

🏖️ Benefits

• Comprehensive Total Rewards program • Reward and recognition opportunities • Competitive compensation and benefits programs • Learning, growth, and development opportunities • Workplace accommodations considered pursuant to applicable law • Flexible work-life balance considerations