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SHINE Technologies · 5 months ago

Licensing Manager

Janesville, WI

Full-time

Onsite

Senior Level

$135K/yr - $165K/yr

7+ years exp

SHINE Technologies is seeking a Licensing Manager who will lead a team responsible for licensing and compliance activities in accordance with applicable regulations. The role involves ensuring the implementation of licensing strategies, interface with regulatory agencies, and oversight of compliance activities.

BiotechnologyEnergyHealth CareManufacturingMedicalMedical DevicePharmaceutical

No H1B

U.S. Citizen Only

Responsibilities

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., 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

Qualification

Nuclear regulatory affairsTitle 10 CFR knowledgeNRC licensing processesMicrosoft Office SuiteAdobe Acrobat ProEffective communicationTeam leadership

Required

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 7 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