Sr. Regulatory Operations Coordinator

About the role

The Regulatory Operations Coordinator supports the Regulatory Affairs Department, focusing on systems to control and update regulatory data and distribution. Key responsibilities include operating within Regulatory Operations systems, coordinating with internal and external resources, and maintaining databases.

Responsibilities

• Operate within Regulatory Operations systems & infrastructure, ensuring information is up to date & accessible.
• Capture, compile, and summarize regulatory data from internal and external sources.
• Support Regulatory personnel in registration activities such as document authentication, submission compilation, document retrieval/update, etc.
• Assure that device listings, import licenses, establishment licenses, and registrations for Balt products are accurate and up to date.
• Assists with audits and inspections, as needed.
• Create, improve, and update metrics on departmental & process performance (KPIs) for reporting on process health & tracking improvements.

Requirements

• Ability to understand and manage the complexities of regulatory documentation.
• Works well in a team environment.
• Works well under pressure in a dynamic, timeline-driven environment.
• Demonstrated MS Office and Adobe Acrobat software skills.
• Demonstrated ability to quickly learn new systems and processes.
• Direct experience with Product Lifecycle Management Systems.
• Direct experience with quality system processes (e.g., Change Orders, Corrective and Preventive Actions, audits, etc.).

Qualifications

• Minimum BA/BS degree or higher in a scientific or technical discipline or relevant field of study.
• 1.5 (one and a half) + years of professional experience working in a regulated industry.

Skills

• Ability to understand and manage the complexities of regulatory documentation.
• Works well in a team environment.
• Works well under pressure in a dynamic, timeline-driven environment.
• Demonstrated MS Office and Adobe Acrobat software skills.
• Demonstrated ability to quickly learn new systems and processes.
• Direct experience with Product Lifecycle Management Systems.
• Direct experience with quality system processes (e.g., Change Orders, Corrective and Preventive Actions, audits, etc.).

Benefits

No specific benefits are mentioned in the job posting.

Pay

$70,000—$80,000 USD

Schedule

Hybrid role that is remote and required to be on-site as specified by reporting manager.