International Regulatory Affairs Specialist

🔥 4 hours ago

🦀 Maryland – Remote

🦀 Maryland – Remote

💵 $75.8k - $121.3k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

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BD

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1897

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🔬 Science

💰 $24M Grant on 2020-07

Healthcare Insurance • Pharmaceuticals • Science

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

• Collaborates with regional colleagues to develop strategies for moderately complex submissions to regulatory agencies worldwide • Interprets regulations and guidance’s ex-U.S. and communicates impacts on registration • Coordinates and supports worldwide product registration requests • Interfaces with global regulatory and marketing contacts to support regional registration requirements • Develops/maintains department procedures for international product registrations • Assembles technical information according to registration requirements • Recognizes and proposes continuous process improvements

🎯 Requirements

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, Pharmacy, or related scientific/technical discipline • Experience coordinating cross-functional inputs (R&D, QA, Manufacturing, Marketing) • Ability to compile and review technical documentation in accordance with country-specific requirements • Understanding of regulatory submission processes and lifecycle management • Strong written and verbal communication skills • Experience working with global teams, regional affiliates, or distributors • Familiarity with SOPs, regulatory procedures, and quality systems (e.g., ISO 13485) • Strong organizational skills and ability to manage multiple submissions/projects simultaneously • Proficiency in Microsoft Office tools (Excel, Word, PowerPoint)

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options