This position will be working in BD Interventional Surgical Devices Business unit on Implantable and Absorbable devices. Under the guidance of the Director of Regulatory Affairs, this position is responsible for the preparation of regulatory submissions required to market new or modified medical devices in both the U.S. and Europe. This position also will be executing on related regulatory affairs activities, such as development, execution and management of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as the objectives of the business. The incumbent will perform essential duties and responsibilities with minimal supervision while providing guidance to more junior regulatory associates.
Coordinate, prepare, and execute applications and supplements to the US FDA with a focus on Class III devices including Pre-Sub, IDE, PMA, and de Novo submissions in a timely manner. Act as liaison with FDA regarding product submissions.
Assess necessity for reporting changes to FDA for proposed device modifications. Prepare robust reporting justifications for changes that do not require supplements or notices.
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, etc.).
Represent RA and demonstrate leadership in complex product development teams by identifying and interpreting relevant regulatory requirements and providing actionableregulatory guidance throughout the product development cycle prior to regulatory submission.
Identify and communicate appropriately quantified risks and mitigation strategies associated with regulatory strategies to stakeholders.
Support development and execution of global regulatory strategies by collaborating closely with international regulatory associates to register our devices worldwide.
Review and approve product labeling, promotional, and advertising materials to ensure regulatory compliance.
Review clinical and human factors protocols to assure collection of appropriate data for regulatory submissionsand regulatory compliance.
Write and update 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.
Remains current on regulations affecting BD products 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 without supervision.
B.S. degree in a technical discipline (e.g., computer science, engineering, bioengineering, biology, chemistry). Advanced degree preferred.
Minimum 6 years Regulatory Affairs experience in medical device or in vitro diagnostic device companies.
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; preferably CDRH and preferably PMA
Experience in negotiating with FDA personnel in the device (CDRH).
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.
Must be able to handle multiple tasks with attention to detail with limited supervision.
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.
Comprehensive knowledge of regulatory requirements for absorbable and implantable devices.
Comprehensive knowledge in new product regulatory strategies.