JOB DESCRIPTION SUMMARY

Regulatory Affairs Coordinator II provides administrative support to the UCC Regulatory Affairs Team including as needed database management and support of regulatory affairs activities and registration process. This position is able to use good judgment in order to complete all tasks in a timely manner with attention to detail and accuracy. Able to act independently and evaluate unusual situations as necessary. Maintain confidentiality in all matters. Able to maintain a high level of organizational, administrative and business skills along with excellent communication and interpersonal skills.

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.

MINIMUM REQUIREMENTS:

• High School diploma or equivalent experience in a regulated environment
• 1-3 Years Regulatory Affairs or Quality Assurance experience with medical technology companies
• Proficient in using Microsoft Word, Access, Excel and Outlook

PREFERRED REQUIREMENTS:

• Strong communication and project management skills
• Must be able to balance multiple tasks
• Attention to details
• Knowledge of Medical Device Quality Systems and Good Documentation Practices
• Able to be Notary Public
  At BD, we prioritize on-site collaboration because we believe it fosters 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.

• Coordinates the Regulatory Change Management process by evaluating requests, compiling information, and summarizing responses. Administers regulatory team systems and uploads documentation to Electronic Document Management System (EDMS), ensuring all regulatory materials are properly maintained and accessible.
• Works closely with Regulatory Affairs Specialists to prepare critical regulatory documentation including registrations, Summary Technical Electronic Documentation (STEDs), and dossiers. Manages extensive word processing needs including FDA documents, certificates, status reports, and presentations.
• Coordinates and responds to external requests for product data, information, surveys, and questionnaires from customers, serving as a key liaison between the organization and its clients for regulatory matters.
• Takes responsibility for updating Standard Operating Procedures (SOPs), Work Instructions (WIs), and policies as needed, ensuring the department maintains compliance with current regulatory requirements and internal standards.
• Handles departmental administrative functions including ordering supplies, creating purchase requisitions using applicable systems, and managing correspondence to support the regulatory affairs team’s operational needs.