Operations Coordinator Jobs

About The Position

Requirements

• Ability to understand and manage the complexities of regulatory documentation.
• Ability to work well in a team environment.
• Works well under pressure in a dynamic, timeline-driven environment
• Demonstrated MS Office and Adobe Acrobat software skills.
• 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.

Nice To Haves

• 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.)

Responsibilities

• Operate within Regulatory Operations systems & infrastructure, ensuring information is up to date & accessible.
• Coordinate between internal and external resources to generate documentation required to support regulatory registration or renewal activities.
• Communicate with international Regulatory, Quality and Sales partners to obtain & act upon feedback regarding potential or confirmed business decisions.
• Track regulatory activity, maintain, and update databases, and ensure that records are complete and current.
• Create, improve and update metrics on departmental & process performance (KPIs) for reporting on process health & tracking improvements
• Obtain, compile & summarize regulatory data from internal and external sources, including data collected from international partners.
• Support Regulatory personnel in registration activities such as document authentication (apostille, legalization, notarization), 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.
• Performs other duties and responsibilities as assigned.

Benefits

• Extended periods of sitting or speaking.
• Light lifting.
• Heavy computer use.