Job Description Summary # Job Description In BD Integrated Diagnostic Solutions – Specimen Management (BD IDS SM), we develop some of the most widely used products in the field of specimen collection including acquisition of the sample, collection into an appropriate container, and also emerging point-of-care applications. Our team has the unique opportunity to be involved with both medical devices and in vitro diagnostics allowing you to broaden your expertise and grow in your career. Our Staff Regulatory Affairs Specialist position is focused on providing the regulatory support for new product development projects and maintaining continued market access of our existing product portfolio. The ideal candidate will be energetic, possess a strong regulatory background and performs well independently and as part of a team. The Staff Regulatory Affairs Specialist will work in BD Integrated Diagnostic Solutions – Specimen Management providing regulatory leadership to cross-functional project teams from early development to new product launches in various markets including the US, EU, and others. The incumbent will develop and execute regulatory strategies to support new 510(k) submissions, CE marking applications, and support our international regulatory team in further launch activities. The incumbent will also support product lifecycle management activities including assessment of the regulatory impact of product changes and line extensions. The ideal candidate will have medical device and in vitro diagnostic experience in the US and EU. Our people make all the difference in our success. Join us in our mission to advance the world of health. Remote Optional (Eastern time zone preferred) BD and COVID-19: To ensure the safety of our associates, BD supports remote work where possible. This position is primarily remote based, however regular visits to the Franklin Lakes, NJ site will be required to ensure adequate business support if/when associates are requested to return to the workplace. **This position does not offer relocation assistance** + Coordinate, prepare, and execute premarket applications to the US FDA including Premarket Notification [510(k)], Pre-Sub, IDE, PMA, and De Novo submissions in a timely manner. Act as liaison with FDA regarding product submissions. + 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, andproviding actionable regulatory guidancethroughout the product development cycle priorto regulatory submission. + Identify and communicate appropriately quantified risks and mitigation approaches associated with regulatory strategies to stakeholders. + Support development and execution of global regulatory strategies by collaborating closely withinternational regulatory associatesto register our devices worldwide. + Lead regulatory efforts required to comply with 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 toensure regulatory compliance. + Review clinical and human factors protocols/reports to assure collection of appropriate datafor regulatory submissions and regulatory compliance. Engages with Medical Affairs in the development and approval of Clinical Evaluation Report) to assure the documents meet regulatory requirements. + Ensures FDA device listings and facility registrations are maintained. + Request FOI information and maintain FOI files in alignment with business strategies. + Develop and maintain standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards. + Coordinate and respond to requests for product information, and questionnaires requested by customers. + Represent BD in relevant external trade organizations and regulatory standards development as necessary to support BD’s continuous product development and compliance efforts. + Remain current on regulations affecting BD products (EU MDR/IVDR, reclassification activities, etc.) and keep the relevant team and supervisors informed about potential impact. + Identify ways to improve the efficiency of current work process and execute them. + Carry out the above tasks with limited supervision. Qualifications: + B.S. degree in a technical discipline (e.g., engineering, bioengineering, biology, chemistry). Advanced degree preferred. + Minimum 5years Regulatory Affairs experiencein medical device or in vitro diagnostic device companies or 3 years of experience with an advanced degree. + Demonstrated ability to resolve problems and to make appropriate regulatory decisions under pressure. + Demonstrated success in the preparation and completion of regulatory submissions (PMA, 510(k), IDE) to FDA and other global regulatory agencies. + Experience in negotiating with regulatory authority personnel (e.g. FDA, Notified Bodies) in medical device and in vitro diagnostic areas. + International product registration experience preferred. Knowledge, Skills, and Abilities: + Proficient in using Microsoft Word, Excel, PowerPoint, and Project. + Strong communication (written, oral) and project management skills. + Able to handle multiple competing tasks with great attention to detail. + Strong critical thinking skills. + Able to work independently to achieve objectives on or before schedule . + Demonstrated global perspective, customer focus, cross-functional collaboration and teamwork skills. + Comprehensive knowledge of US medical device regulations, 21 CFR 820 -Quality System Regulation, and standards, FDA guidance documents, Good Clinical Practice standards, Good Laboratory Practice regulations. + Current knowledge of European quality system standards, and requirements under the medical device directive MDD 93/42/EEC and IVD directive IVDD 98/79/EC. Knowledge of EU MDR and IVDR preferred. Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. #LI-Pro # Primary Work LocationUSA NJ - Franklin Lakes # Additional Locations # Work ShiftNA (United States of America) Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.