Staff Regulatory Affairs Specialist

• Coordinate, prepare, and follow up with FDA Premarket Notification 510(k) submissions in a timely manner. Act as liaison with FDA regarding product clearance.
• Assess necessity for submitting a 510(k) application for proposed device changes. Prepare internal "Non-Filing Justifications" (U.S.) for changes that do not require a 510(k) submission.
• Prepare technical files / dossiers for International Registrations with appropriate input from various functions (R&D, Quality, Manufacturing, etc.) in a timely manner.
• Review and approve labeling, promotional and advertising materials to ensure regulatory compliance.
• Represent RA in product life cycle development teams by reviewing, approving, and completing requirements.
• Coordinate and collect specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments as necessary.
• Represent RA in design teams and projects by providing regulatory guidance throughout the product development cycle and coordinating team inputs for regulatory submissions.
• Support International Registrations as it relates to product changes and/or new product launches.
• Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies on an as-needed basis.
• Coordinate and respond to requests for product data/information, surveys/questionnaires requested by customers.
• May provide leadership by assigning work and resolving complex problems.

• Bachelor's degree in Regulatory Science, Biomedical, Pharmaceutical, or related scientific field (or equivalent)
• Minimum of 5 years of Regulatory Affairs experience in the medical device industry, preferably with FDA Class II and/or Class III devices

• Medical device regulatory submission experience for the U.S., Europe, and/or international markets.
• Demonstrated success in the preparation and completion (including negotiations) of regulatory submissions (PMA, 510(k), IDE) to FDA and other regulatory agencies
• Experience supporting product development, design changes, and product lifecycle management.
• Ability to evaluate technical/clinical data and independently resolve complex regulatory issues.
• Knowledge of regulatory requirements across V&V, risk management, usability, reprocessing, biocompatibility, and software development.
• Demonstrated ability to resolve problems and to make appropriate regulatory decisions under pressure.
• Strong cross-functional communication and risk-based regulatory strategy development.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.