Regulatory Affairs Lead

2 weeks ago


Oak Ridge, TN, United States Spectra Tech Full time

The Regulatory Affairs Lead will lead the development of the reactor and facility safety basis strategy, interactions with regulatory agencies, coordinate safety and environmental compliance activities, and provide strategic guidance on regulatory issues. The Lead will supervise a team direct report and matrixed staff in regulatory strategy, safety basis documentation, requirements management, probabilistic risk assessment, environment management, hazards analysis, and other relevant fields. Additionally, this position interacts directly with regulatory bodies, develops the safety and compliance documentation, and enforces meticulous quality control measures.

This position demands strong expertise in nuclear licensing processes and and the ability to efficiently navigate complex regulatory frameworks. The incumbent will be responsible for developing regulatory strategies to ensure compliance with DOE and applicable regulations. Additionally, this role requires a thorough understanding of the safety basis development of a nuclear reactor. The incumbent will be responsible for ensuring regulatory engagement is proactive, not reactive.
Major Duties/Responsibilities:

Regulatory Compliance & Strategy:

Develop and implement risk-informed, performance-based regulatory strategies to ensure compliance with DOE, NRC, and other applicable nuclear reactor and nuclear facility regulations.

Ensure adherence to Facility Safety under DOE O 420.1C, Safety in Design under DOE-STD-1189-2016, reactor safety following the General Design Criteria under NRC's 10 CFR 50 Appendix A as well as other applicable codes and standards.

Maintain awareness of evolving nuclear reactor regulatory requirements and guidance documents, especially for advanced reactor risk-informed, performance-based approaches, and integrate updates into project processes as appropriate.

Coordinate safety analysis and probabilistic risk assessment with Nuclear Reactor Analysis team.

Coordinate regulatory reviews, approvals, and project milestones.

Lead hazards analysis and mitigation activities.

Coordinate safety strategy with the Nuclear Facility Safety Division.

Lead environmental compliance activities.

Stakeholder & Agency Engagement:

Serve as the primary project regulatory liaison with DOE, NRC, state, and other agencies.

Facilitate meetings, inspections, and audits with regulatory bodies.

Ensure accurate and timely reporting to oversight agencies.

Documentation & Risk Management:

Work collaboratively with nuclear safety staff, researchers, and support personnel from across ORNL in the development, review, submittal for approval, and maintenance of safety basis documents, including an amended safety basis for HFIR.

Oversee the preparation and submission of regulatory documentation.

Maintain accurate records in accordance with regulatory requirements.

Identify regulatory risks and develop mitigation strategies.

Respond to regulatory inquiries and ensure corrective actions are implemented.

Leadership & Team Management:

Develop and lead a team of direct reports as well as matrixed staff.

Promote a team approach where individual expertise is recognized and employed.

Provide mentoring, training, and oversight to regulatory affairs personnel.

Foster a culture of compliance and continuous improvement.

Facilitate and sustain a strong nuclear safety culture and takes positive actions to address nuclear safety concerns.

Communication:

Provide clear and accurate communication to all levels of management, staff, and stakeholders.

Develop clear and concise presentation materials that assist in the timely delivery of project messaging.

Participate and present project information at reviews, conferences, and workshops.

Deliver ORNL's mission by aligning behaviors, priorities, and interactions with our core values of Impact, Integrity, Teamwork, Safety, and Service. Promote equal opportunity by fostering a respectful workplace - in how we treat one another, work together, and measure success.
Basic Qualifications:
A BS degree in nuclear engineering, mechanical engineering, or a related field with 12 years, MS with 10 years, or PhD with 8 years of relevant experience.
Experience in nuclear reactor regulatory compliance and alignment with nuclear reactor safety analysis with a nuclear regulatory body and/or within the nuclear industry.
Expertise in DOE and/or NRC nuclear reactor regulations, licensing, and safety basis development.
Experience in nuclear reactor regulatory engagement, audits, and compliance strategies.
Strong leadership, problem-solving, and communication skills.
Preferred Qualifications:

An MS degree in nuclear engineering, mechanical engineering, or a related field.

Experience with DOE nuclear facility upgrades and safety analysis.

Knowledge of environmental compliance regulations.

Familiarity with hazard analysis and risk mitigation strategies.
Special Requirements:

Must be available for domestic and international travel.

This position requires the ability to obtain and maintain an HSPD-12 PIV badge.

This position requires the ability to obtain and maintain a clearance from the Department of Energy. As such, this position is a Workplace Substance Abuse (WSAP) testing designated position. WSAP positions require passing a pre-placement drug test and participation in an ongoing random drug testing program.



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