Careers

The Senior Regulatory Manager is responsible for managing our medical device regulatory affairs and our regulatory team. This role manages the planning and execution of Imricor’s advanced regulatory strategies to support product development and lifecycle management, ensuring timely submissions and approvals in the US, EU, and international markets. The Senior Regulatory Manager also provides leadership to cross-functional teams ensuring continuous improvement in regulatory processes and systems in alignment with Imricor’s Quality Management System and environmental, health, and safety policies.

The Regulatory Specialist II is responsible for supporting creation, development, and implementation of regulatory submissions to the EU notified body, the US FDA, and other country specific regulatory bodies. The position is also responsible for ensuring continued compliance with regulatory agency approvals including change impact reviews. This position is responsible for complying with the Imricor Quality Management System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.

The Senior Regulatory Specialist is responsible for planning, managing, and implementing regulatory submissions to the EU-notified body, the US FDA, and other country-specific regulatory bodies. This position ensures continued compliance with regulatory agency approvals including change impact reviews. This position is also responsible for complying with the Imricor Quality Management System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.

The Assembler I position assembles and subassemblies complex catheter-based medical devices in a cleanroom environment. This position is responsible for complying with the Quality System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.

The Regulatory Operations Specialist is responsible for assisting in the preparation and submittal of regulatory documentation to agencies such as the FDA, EU Notified Bodies, and other global regulatory authorities. Also, this position is responsible for certification management with agencies. This position is responsible for complying with the Imricor Quality Management System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.

This design assurance engineer position supports product development to ensure a successful production launch and delivery of the highest quality product to the customer. This position also supports design change and other quality initiatives. This position interacts closely with the Engineering team as well as Operations, Quality Systems, Quality Assurance, Marketing, and Regulatory. This position is responsible for complying with the Imricor Quality Management System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.

The Field Clinical Engineer based out of Europe is responsible for supporting customers perform clinical research and commercial cases through training, installation, and technical support prior to and during procedures. The Field Clinical Engineer has authority to install, test, and manage new and used equipment (including investigational equipment) for all Imricor Customers. This position must understand MR guided interventional procedures (including Electrophysiology Procedures) and excel in ability to work with physicians and MR and EP technicians as well as troubleshoot, repair, and service equipment in an efficient and compliant manner. This position will interface with an international sales team, as well as a US-based Operations, Engineering, and Clinical team. This position is in a fast-growing medical device company and requires 95% travel.

The Senior Clinical Research Specialist (Sr CRS) will conduct clinical research throughout all stages of a project, including design, implementation, and execution. This role will be responsible for one or multiple global clinical studies at all phases (feasibility, pivotal, post-market). The Sr CRS will be responsible for collecting, analyzing, and reporting accurate trial data to support expanded market access. This position is responsible for complying with the Quality System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.

The R&D Engineering Manager will direct, manage, and supervise engineers and technicians in the research, design, development, and verification/validation of capital equipment. This position is responsible for complying with the Quality System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.