Job Description Summary

As Staff Regulatory Affairs Specialist, you will primarily focus on maintaining continued market access within our existing product portfolio and provide regulatory support for new product development projects. This exciting position will include support of BD joint venture priorities including innovative product launches with PreAnalytiX.

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. 

Our vision for Speciman Management at BD

Specimen Management (BD SM) develops 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.

Key responsibilities will include:

• 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, 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 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 (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.

• Review clinical and human factors/usability protocols/reports to assure collection of appropriate data for regulatory submissions and regulatory compliance.

• Engages with Medical Affairs in the development and approval of Clinical Evaluation Reports to assure the documents meet regulatory requirements.

• Ensures FDA device listings and facility registrations are maintained.

• Request FOI information and maintain FOI files in alignment with business strategies.

• Develop and maintain 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 lead/participate in regulatory standards development/compliance activities as necessary to support BD’s continuous product development and compliance efforts.

• Remain current on regulations affecting BD products (EU MDR/IVDR, 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.

• Carry out the above tasks with limited supervision.

About you: To be successful in this role, you require:

• Minimum bachelor's degree in a technical discipline (e.g., engineering, bioengineering, biology, chemistry.) Advanced degree preferred.

• Minimum 5 years Regulatory Affairs experience in medical device or vitro diagnostic device companies or 3 year