Regulatory Affairs Specialist

Responsibilities

• Serve as the Regulatory Affairs Subject Matter Expert (SME) on various new product development (NPD) teams
• Provide regulatory guidance, develop strategies, and conduct risk assessments for in vitro diagnostic (IVD) products
• Organize and lead FDA and EU IVDR submissions, including Pre-IDEs, PMA, De Novo, 510(k), and CLIA Waivers
• Act as the primary point of contact for FDA and Notified Body review teams during submission communications
• Work cross-functionally with R&D, Medical Affairs, Quality, Marketing, and Program Management
• Identify and address potential regulatory risks within project plans and propose continuous process improvements

Requirements

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, Pharmacy, or a related scientific/technical discipline
• Minimum 5 years of directly related regulatory experience in the in vitro diagnostic (IVD) or medical device sectors
• Proven experience with FDA submissions (PMA, 510(k), De Novo)
• Knowledge of EU IVDR Technical Files and Dossiers
• Familiarity with ISO 13485 and quality systems

Preferred Qualifications

• RAPS Certification
• Demonstrated success in preparing, filing, and negotiating complex regulatory submissions
• Experience interpreting subjective and complex aspects of specific regulations
• In-depth understanding of advanced technical/scientific principles related to complex product lines or manufacturing processes

About the Company

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our purpose, and we strive to find transformative solutions that turn dreams into possibilities. We foster a culture of innovation and collaboration to improve patient outcomes and drive breakthroughs in healthcare worldwide.