Regulatory Affairs Coordinator II

We are the people who give possibilities purpose

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.

Job Description

Responsibilities:

• 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.

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:

• Bachelor Degree, BS
• 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.

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Why Join Us?

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 healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visithttps://bd.com/careers.

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 or veteran status, and other legally protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

USA GA - Covington BMD

Additional Locations

Work Shift

US BD 1st Shift 8am-430pm (United States of America)