Manager, Regulatory Affairs
This position will be working in BD-Medication Management Solutions business on projects that may span the Infusion, Dispensing and Technology Solutions portfolios. Under the guidance of the Associate Director of Regulatory Affairs, the Regulatory Affairs Manager is responsible for the preparation of regulatory submissions required to market new or modified medical devices in both the U.S. and Europe. The Regulatory Affairs Manager will carry out 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.
Duties and Responsibilities:
- 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, 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 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.
- Lead regulatory efforts required to comply with new regulations and requirements; i.e., EU MDR, MDSAP.
- 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 submissions and regulatory compliance.
- Ensure FDA device listings and facility registrations are maintained. Maintain product listings and facility registrations with FDA.
- Request FOI information and maintain FOI files in alignment with business strategies.
- 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.
- Remain current on regulations affecting BD products (21st Century Cures Act, MDDS, 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.
- Performs other duties and assignments as required.
- B.S. degree in a technical discipline (e.g., computer science, engineering, bioengineering, biology, chemistry). Advanced degree preferred.
- Minimum five years (7-10 preferred) Regulatory Affairs experience with medical device company.
- 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.
- Experience in negotiating with FDA personnel in the device (CDRH) and drug (CDER) 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.
- Must be able to handle multiple tasks with attention to detail.
- 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 complex interconnected medical devices; e.g., electro-mechanical devices (EMC/EMI), software in a medical device, software as a medical device, clinical decision support, mobile medical apps, general wellness products, medical device data systems, etc.
“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.”
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Job posted: 2020-09-22