Staff Regulatory Affairs Specialist





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Job Description

Summary

In BD – Specimen Management (BD 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 primarily focused on maintaining continued market access of our existing PreAnalytiX and Lab Specimen Management product portfolios, in addition to opportunities to provide regulatory support for new product development projects. The ideal candidate will be energetic, possess a strong regulatory background and perform well independently and as part of a team.

The Staff Regulatory Affairs Specialist will work in BD – 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 support product lifecycle management activities for PreAnalytiX and Lab Specimen Management products, including assessment of the regulatory impact of product changes and line extensions. The incumbent may also 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 ideal candidate will have medical device and in vitro diagnostic experience in the US and EU, as well as experience with project management activities.

Job Responsibilities:

• 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.

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.

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