Senior Regulatory Affairs Representative

🔥 15 minutes ago

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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

• Develop, implement, and maintain regulatory strategies and submissions for BD APM products • Ensure compliance with EU regulations and standards • Support product lifecycles • Prepare, review, and submit regulatory documents for product approvals, registrations, and renewals • Interpret and apply global regulatory requirements and guidance to APM products and processes • Participate in cross-functional project teams and provide regulatory input throughout product development • Prepare and review labeling, promotional materials, and technical documentation for regulatory compliance • Support regulatory intelligence activities and assess the impact of regulatory changes on APM products • Participate in internal and external audits, providing regulatory expertise and documentation • Develop and maintain regulatory files and databases

🎯 Requirements

• Contribute to regulatory strategies and submissions for BD APM products • Ensure compliance with EU regulations and standards • Apply global regulatory requirements and guidance to products and processes • Provide regulatory input throughout the product development lifecycle • Support regulatory compliance reviews of labeling, promotional materials, and technical documentation • Monitor global regulatory changes and assess their impact • Provide regulatory expertise during internal and external audits • Maintain accurate and accessible regulatory files and databases

🏖️ Benefits

• Comprehensive Total Rewards program • Reward and recognition opportunities • Competitive compensation and benefits programs • Learning, growth, and development opportunities • Face-to-face collaboration culture supporting learning, progress, and success