Job Description Summary

BD Specimen Management (SM) offers a comprehensive range of solutions spanning the entire specimen management continuum and beyond—starting with the clinically-differentiated 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.

Job Description

We are the makers of possible 

 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

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 Specimen Acquisition 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 Specimen Acquisition 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.Our people make all the difference in our success. Join us in our mission to advance the world of health.

This is a hybrid position where the candidate is required to be in the office a minimum of 4 days a week. Office location is in Franklin Lakes, NJ.

**This position does not offer relocation assistance**

Responsibilities:

• Coordinate, prepare, and execute US and EU regulatory strategies and applications for complex products (510(k), Pre-Sub, De Novo submissions, MDR/IVDR technical files, etc.) in a timely manner.

• Lead development and execution of global ROW (rest of the world) regulatory strategies by collaborating closely with international regulatory associates to register devices worldwide.

• Lead regulatory strategies for Change Controls (CC) and establish regulatory requirements for complex and simple changes and ensure license/registration continuity.

• Represent RA and demonstrate leadership in complex product development teams by translating global requirements into design inputs, evidence strategies, and regulatory submissions.

• Own regulator interactions for defined programs with minimal supervision; negotiate scope/expectations and secure written agreements/commitments.

• 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 to ensure regulatory compliance.

• Develop and maintain standard operating procedures, work instructions, and policies to