The interpretation and application of regulations and standards governing U.S. clinical laboratories are essential functions of this role. The U.S. Laboratory Regulatory Manager is responsible for overseeing and managing the Company's compliance with regulatory frameworks applicable to U.S. clinical laboratory operations. This position is expected to remain abreast of applicable regulations, monitor the regulatory landscape for emerging trends and communicate trends that may impact Company policies and procedures. The incumbent will be a part of the Regulatory Affairs & Quality Assurance Leadership Team and will be expected to further the company regulatory and quality function through proactive participation in and contributions to this team and the broader company goals. While the primary focus of the role is on US laboratory regulations, there will be scope for broader regulatory activities and objectives related to US FDA regulations and international registrations.
The physical demands described within the Position Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Minimal travel required including international travel. Job requires employee to walk considerable distances in the facility during the course of his or her work.