Regulatory Affairs Coordinator II

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

Additional information

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.

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