Staff Regulatory Affairs Specialist (Franklin Lakes)

Staff Regulatory Affairs Specialist

BD Specimen Management (SM) offers a comprehensive range of solutions spanning the entire specimen management continuum and beyondstarting with the BD Vacutainer range of blood and urine specimen collection and specimen management products, to sample analysis and accurate reporting. The Staff Regulatory Affairs Specialist is responsible for preparation of US and CE marking submissions / registration activities, completing comprehensive regulatory assessments for product sustaining activities, and supporting development and execution of global regulatory strategies by collaborating closely with international regulatory associates to register our devices worldwide.

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues. Here, you'll help us maintain our high standards from a regulatory perspective at all levels, with a keen focus on submissions. It requires acute attention to detail, excellent communication skills and a passion to keep learning and updating your knowledge, which we'll help you do with regular learning opportunities.

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 implement 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 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 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.
• Carry out the above tasks with limited supervision.

Qualifications :

Knowledge and Skills :

At BD, we prioritize on-site collaboration because we believe it cultivates 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.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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