Regulatory Operations Coordinator

About Balt Our purpose is to improve the lives of 150,000 patients in 2026. Our story Balt is a rapidly growing pioneer in an exceptional field. For 45 years, Balt has been leading the way - collaborating with physicians and institutions to develop elegant medical devices.  Our products are being used by physicians across the world, and we have 13 offices in 11 countries – and counting. We introduced one of the first neurovascular intervention devices in 1977 and now offer the world's broadest portfolio of medical devices for stroke. As the premier global neurovascular platform always seeking to expand beyond boundaries, we are now bringing our innovation to the peripheral vascular space. We are proud of our mission, our people, and the incredible work we accomplish together as we empower physicians to save lives. Why Join Balt? Join a passionate team, dedicated to making a difference. Working at Balt means giving meaning to your work! Pride is a strong part of our identity. We are a close-knit team, with strong mission, vision and values that guide our day-to-day. Recognition of work, respect, and our multicultural community are key aspects of the employee experience and contribute to our continued success. No matter the country, we take care of you. Would you like to be part of our story? Don't hesitate, come and join us! About this opportunity – Regulatory Operations Coordinator Description The Regulatory Operations Coordinator will support across the Regulatory Affairs Department, with a focus on systems to control & update regulatory data and distribution. The Regulatory Operations Coordinator will coordinate inter- and intra-departmentally to support Regulatory activities and infrastructure. Job Responsibilities: 1. Operate within Regulatory Operations systems & infrastructure, ensuring information is up to date & accessible. 2. Coordinate between internal and external resources to generate documentation required to support regulatory registration or renewal activities. 3. Communicate with international Regulatory, Quality and Sales partners to obtain & act upon feedback regarding potential or confirmed business decisions. 4. Track regulatory activity, maintain, and update databases, and ensure that records are complete and current. 5. Create, improve and update metrics on departmental & process performance (KPIs) for reporting on process health & tracking improvements 6. Obtain, compile & summarize regulatory data from internal and external sources, including data collected from international partners. 7. Support Regulatory personnel in registration activities such as document authentication (apostille, legalization, notarization), submission compilation, document retrieval/update, etc. 8. Assure that device listings, import licenses, establishment licenses, and registrations for Balt products are accurate and up to date. 9. Assists with audits and inspections, as needed. 10. Performs other duties and responsibilities as assigned. Qualification Requirements: 1. Ability to understand and manage the complexities of regulatory documentation. 2. Ability to work well in a team environment. 3. Works well under pressure in a dynamic, timeline-driven environment 4. Demonstrated MS Office and Adobe Acrobat software skills. Skills: 1. Demonstrated ability to quickly learn new systems and processes. 2. Direct experience with Product Lifecycle Management Systems 3. Direct experience with quality system processes (e.g., Change Orders, Corrective and Preventive Actions, audits, etc.) Pre-requisites / Job Experience: 1. Minimum BA/BS degree or higher in a scientific or technical discipline or relevant field of study. 2. 1.5 (one and a half) + years of professional experience working in a regulated industry. Physical Requirements: Hybrid role that is remote and required to be on-site as specified by reporting manager. Extended periods of sitting or speaking. Light lifting. Heavy computer use. Must adhere to the company’s safety practices by performing work safely and in accordance with established standards. Work Environment: Working conditions are normal for an office environment. The above information on this description have been designed to indicate the general nature of work performed by employees within this position. This job description is only a summary of the typical functions of the job, not an exhaustive or comprehensive list of all possible responsibilities. tasks, and duties, and does not limit the assignment of additional duties for this position. Balt Group is an Equal Employment Opportunity employer. More information please go to www.baltgroup.com Please be aware of a current job offer scam perpetrated through the use of the internet. The scammers frequently misappropriate and use a company’s log and photos to give the appearance of legitimacy. The scam preys upon those seeking employment and uses false and fraudulent offers of employment with employers, such as Balt Inc to steal from the victims. Balt believes that one of the best ways to put a stop to this scam is to make sure you are aware of it. Balt’s job recruitment process involves live communication: in person, telephone, and/or video interviews in most cases. #LI-FW1 Pay Range $70,000 — $80,000 USD