Licensing Manager
SHINE Medical Technologies
SHINE Technologies is seeking a Licensing Manager to lead a team of licensing staff responsible for licensing and compliance activities conducted in accordance with applicable local, state, and federal regulations. The Licensing Manager ensures adequate implementation of SHINE’s licensing strategies via the coordination of work activities, identifying and resolving licensing-related issues, and ensuring alignment between technical and licensing deliverables. Long term responsibilities will include oversight of compliance and support activities. The Licensing Manager is SHINE’s primary interface with regulatory agencies, including the U.S. Nuclear Regulatory Commission and the State of Wisconsin, Department of Health Services.
Duties and Responsibilities:
Specific duties and responsibilities include, but are not limited to:
- Define, develop, and execute SHINE’s licensing strategies.
- Oversee the execution of licensing activities, including the development and maintenance of regulatory engagement plans, the conduct of pre-application engagements, and the coordination of reviews by regulatory agencies.
- Oversee the development of licensing correspondence to regulatory agencies (e.g., new license applications, amendment requests, application supplements, responses to requests for additional information, exemption requests), ensuring the completeness and accuracy of the licensing correspondence.
- Oversee the maintenance of the SHINE licensing bases, including the Safety Analysis Reports for SHINE facilities licensed under 10 CFR Part 50 and the programs described therein.
- Interface with regulatory agencies in the planning of regulatory engagements, regulatory reviews, and oversight activities.
- Ensure documentation developed by regulatory agencies (e.g., Safety Evaluation Reports, Inspection Reports) is accurate and consistent with the applicable SHINE licensing basis.
- Oversee implementation of the SHINE corrective action program.
- Lead resolution of key strategic licensing issues.
- Develop and manage the departmental budget.
- Participate in industry-led and regulator-led regulatory activities.
- Perform other duties as assigned.
- Bachelor’s degree in engineering, scientific discipline, or related field, or equivalent experience such as a Senior Reactor Operator License or the Naval Nuclear Propulsion Program.
- A minimum of 10 years of nuclear experience in regulatory affairs, engineering, operations, or quality assurance.
- Demonstrated knowledge of Title 10 of the Code of Federal Regulations (CFR), with an emphasis on 10 CFR Part 50.
- Demonstrated knowledge of regulatory guidance applicable to non-power production and utilization facilities and radioactive material licenses.
- Demonstrated knowledge of NRC and Agreement State licensing processes.
- Proficient in Microsoft Office Suite and Adobe Acrobat Pro.
- Ability to communicate effectively with all levels within the organization, as well as interface with regulators, contractors, and suppliers.
Eligibility for employment is conditioned on the applicant’s ability to qualify for access to information subject to U.S. Export Controls. Additionally, applicant’s eligibility may be conditioned based upon meeting the Nuclear Regulatory Commission requirements for access to Safeguards Information, which typically requires a pre-employment drug screen, fingerprinting and criminal background check.
SHINE values diversity in all its forms as a critical component of innovation, which is fundamental to our success. Every member of the SHINE community benefits from the talents and experiences of our peers, from the mutual respect we exercise, and from the responsibility we take for our actions.
SHINE Technologies is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.