Staff Regulatory Affairs Specialist

Minimum Qualifications

• 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 be proficient at 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 using Microsoft Word, Excel, PowerPoint

• Coordinate, prepare, and complete premarket applications to the US FDA, including Premarket Notification [510(k)], Pre-Sub, and De Novo submissions in a timely manner. Act as liaison with FDA regarding product submissions. Experience in Safer Technologies Program (STeP), Breakthrough Device designation, and Predetermined Change Control Plans (PCCPs) is a plus.
• Assess necessity for submitting a 510(k) application for proposed device modifications. Prepare robust non-filing justifications for changes that do not require a 510(k) submission.
• Coordinate and prepare technical files for submission to European Notified Bodies for timely CE marking of new and modified products, with appropriate input from supporting functions (R&D, Quality, Manufacturing, Medical Affairs, etc.).
• Represent RA and demonstrate leadership in complex product development teams by identifying and interpreting relevant regulatory requirements, and providing actionable regulatory guidance throughout the product development cycle prior to regulatory submission.
• Identify and communicate appropriately quantified risks and mitigation approaches associated with regulatory strategies to partners.
• Assist and manage Notification of Change (NOC)/International Regulatory Affairs assessments of PLM/Sustaining activities to ensure regional/country requirements of US, EU and Rest of World (ROW) are captured in Regulatory strategy development.
• Develop regulatory strategies for Change Controls (CC) and establish Regulatory Requirements.
• Support development and execution of global regulatory strategies by collaborating closely with international regulatory associates to register our devices worldwide.
• Lead regulatory efforts that are required to follow new regulations (e.g., EU MDR/IVDR, MDSAP) and other requirements including changes to international standards.
• Review and approve product labeling, promotional materials, and advertising materials to ensure regulatory compliance.
• Coordinate and respond to requests for product information, and questionnaires requested by customers.
• Ensure FDA device listings and facility registrations are maintained.
• Develop and maintain standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.
• Represent BD in relevant external trade organizations and lead/participate in regulatory standards development/compliance activities as necessary to support BD’s continuous product development and compliance efforts.
• Identify ways to improve the efficiency of current work process and implement them.