Regulatory Affairs Manager jobs in North Dakota

Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)

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Water Utility Regulatory Manager
  • City of Fargo
  • Fargo, ND FULL_TIME
  • Under general supervision, the Water Utility Regulatory Manager performs activities related to regulatory compliance across all aspects of utility operation. The overarching goal is to position the Water Utility to be ‘audit ready’ at all times for the many regulations it falls under. A significant function of the position will be implementing and maintaining new Lead & Copper Rule requirements, effective in 2024. The position will be responsible and accountable for regulatory compliance of rules from various agencies such as the US Environmental Protection Agency (EPA), North Dakota Department of Environmental Quality (DEQ), Occupational Safety and Health Administration (OSHA), and other agencies. The Regulatory Manager will also assist with staff training and public outreach. Written, verbal communications and program management are essential. Incumbent will facilitate the implementation of changes within the water utility or those recommended by City Administration, including new software, regulatory programs, policy changes, and technical advances in water system operation.

    Scope of Responsibility:
    The Water Utility Regulatory Manager is responsible for the quality and accuracy of his/her own work. Regulatory program compliance tasks require significant attention to detail navigating complex local and federal regulations. Incumbent serves to establish benchmarks, Key Performance Indicators (KPIs), and targets for Water Utility operational and regulatory performance: water quality, regulatory compliance, and budget impacts. The position requires a long-term approach to their scope of responsibility and will assist in mentoring and training other water utility staff. Incumbent is expected to be actively involved with decisions and planning for the utility in a team-oriented organization.Essential Duties and Responsibilities:
    1. Monitors Water Utility infrastructure (source water, treatment processes, distribution system, etc.) for quality control and regulatory compliance through various available data systems such as Supervisory Control and Data Acquisition (SCADA), Hach Water Information Management Solutions (WIMS), US Geological Survey (USGS), and other available tools. Assist in forecasting Water Treatment Plant (WTP) adjustments under the follow process areas within the Lime Softening Water Treatment Plant (LSWTP) and Membrane Water Treatment Plant (MWTP):
      1. Raw water source selection and water quality monitoring;
      2. (LSWTP & MWTP) Pretreatment using flocculation, sedimentation, and plate settlers for turbidity and organic removal;
      3. (LSWTP) Lime-soda ash softening;
      4. (LSWTP & MWTP) Ozonation that includes advanced oxidation using peroxide for disinfection, taste/odor control, ozone quenching, filter head loss control, and disinfection byproduct control;
      5. (LSWTP & MWTP) Filtration with biological Granular Activated Carbon (GAC) filters for turbidity removal, taste/odor removal, emerging contaminant removal, and biodegradable organic carbon (BDOC) removal;
      6. (LSWTP) Ultraviolet (UV) treatment for EPA credit with waterborne pathogen inactivation;
      7. (MWTP)Ultrafiltration for particle removal and EPA regulatory credit for pathogen removal;
      8. (MWTP) Reverse Osmosis for removal of salt, organics, and Emerging Contaminants (ECs);
      9. (LSWTP & MWTP) Final water treatment including stabilization, corrosion control, and other finished water targets;
      10. Water distribution system operation including pumping/levels, water sampling for EPA regulatory compliance and investigative purposes, and continuously monitoring instrumentation data;
      11. (LSWTP & MWTP) Water quality monitoring with both continuously monitoring instrumentation and benchtop analysis;
      12. (LSWTP & MWTP) Chemical feed system operation and troubleshooting;
      13. Control system information interpretation;
      14. Participate in any regulatory inspections by the North Dakota Department of Environmental Quality, United States EPA, or other agencies.
      15. Oversee and complying with NPDES permits.

    2. Team leader for implementing and maintaining all Lead and Copper Rule compliance requirements including, but not limited to, the following: 
      1. Oversee Lead Service Line Inventory (LSLI) requirements;
      2. Oversee required water sampling for lead in the Fargo water distribution system for regulatory concentration calculations related to the EPA Action Level and other statistical results;
      3. Communicate with State and Federal regulators regarding Lead & Copper Rule (LCR) requirements and required utility actions;
      4. Provide technical support to regional customers regarding LCR;
      5. Oversee water sampling for lead in schools, daycare facilities, and other affected water customers;
      6. Provide education regarding LCR to customers, utility staff, and others;
      7. Provide media interviews regarding LCR implementation as needed;
      8. Assist with implementing any Lead Service Line Replacement (LSLR) programs;
      9. Provide homeowners with temporary Point-of-Use devices or lead removal filtration equipment aligning with LSLR per LCR requirements;
      10. Lead corrosion mitigation studies as needed;
      11. Team lead or assist with any other LCR requirements.

    3. Performs safety program implementation and maintenance duties related Occupational Safety and Health Administration (OSHA), National Electric Code (NEC), and other requirements:.
      1. Liaison with Human Resources personnel such as the Safety Manager and Training & Development Coordinator on safety topics related to the Water Utility;
      2. Coordinate with Minnesota Municipal Utilities Association (MMUA) representatives or other safety organizations regarding safety program implementation, planning, and training;
      3. Participate in Safety Committee and/or Safety Committee directive implementation, including Incident Investigates;
      4. Develop and provide safety related training to Water Utility staff, new hires, contractors, and visitors to facility;
      5. Assist in the development of safety Standard Operating Procedures (SOPs), Job Hazard Analysis (JHA) documents and Lock-Out/Tag-Out procedures for Water Utility facilities;
      6. Foster the use of Confined Space permits, Hazard Elimination/Control Worksheets, Near Miss Reports and other safety related tracking documents;
      7. Assist in maintaining a compliant Safety Data Sheets (SDSs) inventory for Water Utility facilities;
      8. Conduct Safety Inspections and safety related audits for the Water Utility;
      9. Promote the involvement of all Water Utility personnel and supervisors in the safely program implementation and development;
      10. Assist with Community Right-to-Know information and required submittals.

    4. Team member for Clean Air Act requirements pertaining to Process Safety and Risk Management Plan (RMP) for Chlorine and Ammonia:
      1. Prepare or assist in preparing RMP for submittal to EPA every five (5) years;
      2. Help organize and monitor to keep compliance tasks on required schedule for audits, operating procedure review, staff training, release scenarios, emergency response planning, and other program elements;
      3. Assist in integrating RMP required maintenance tasks into a Computerized Maintenance Management System (CMMS) to be implemented in the future;
      4. Assist with any Incident Investigation under the RMP;
      5. Conduct, coordinate, or assist with any Water Utility staff training under the RMP;
      6. Liaison with other City of Fargo Departments or other agencies for training exercises and other coordination needs;
      7. Assist with equipment changes or modifications pertaining to the RPM;
      8. Participate in self-audits or any federal audits of the RMP.

    5. Serve as Team Leader or assist with best practices implementation and compliance for any local, state, or federal regulations:
      1. Design, implement, and maintain schedules, task calendars, checklists or other tracking tools to verify compliance with regulatory requirements or adherence to operational best practices and facility Key Performance Indicators (KPIs);
      2. Assist with annual reviews of Water Utility plans such as Emergency Response Plan, Drought and Water Service Management Plan, and other utility planning documents;
      3. Assist in the development and maintenance of utility Standard Operating Procedures (SOPs) and Operations & Maintenance Manual for the Water Utility;
      4. Develop and conduct staff training for various best practices, SOPs, or regulatory requirements;
      5. Review and monitor technical information related to potential future regulations, water research, and technology advances in the water field;
      6. Perform utility self-audits and self-assessments toward improving Water Utility operations;
      7. As needed, present to the City Commission or Utility Committee on regulatory and operations topics.

    6. Works as a team with other water utility groups: operations, maintenance, laboratory, and controls.
      1. Helps with workload in other groups as needed or with larger water utility maintenance projects;
      2. Coordinates with other water utility groups to assist in areas that technical assistance is needed or when a special project needs completions;
      3. Communicates respectfully and fosters teamwork within the water utility and in coordination with outside groups;
      4. Provides training and support to utility staff with new optimization and workflow strategies.

    7. Communicates courteously and professionally and maintains working relationships with others in carrying out job functions.
      1. Receives calls from the public, vendors, contractors, and consulting engineers;
      2. Communicates and discusses technical information with vendors, contractors, consulting engineers, and others;
      3. Frequently interacts with others in the work unit to exchange detailed and/or technical information.

    8. Performs all job duties in compliance with safety guidelines and with an ongoing awareness of safety practices.
      1. Knows and follows department and city rules as well as sound work and safety practices in order to accomplish the job objectives and avoid injury or loss;
      2. Wears proper protective equipment when policy requires or conditions indicate a need exists and utilizes proper body mechanics and ergonomics while performing work;
      3. When potentially unsafe conditions are observed makes efforts to avoid or correct them if they are controllable and draws them to the attention of the responsible supervisor or safety representative in a timely manner.

    9. Train, mentor, and assist water utility operators in the following positions: Operator-Apprentice, Operator I, Operator II, Operator III, and Operator IV.
      1. Facilitate learning about the specific details of design, operation, and history of Fargo’s water infrastructure: raw water, water treatment, and water distribution.
      2. Explain and discuss the theory of operation (mechanical, chemical, biological, monitoring capabilities) of all water treatment processes.
      3. After becoming proficient, relay information regarding ongoing studies and optimization work. Facilitate the implementation by operators of new optimization strategies that show promise of a favorable cost/benefits ratio.
      4. Educate operator about the data available on the control system from online instrumentation (source water, treatment, distribution). Discuss actions to be taken in response to SCADA information.
      5. Solicit ideas from operators that will help improve water system operation and can be implemented.
      6. Develop a training program related to all the regulatory requirements in the MWTP and LSWTP, train operators and other staff that are interested.

    10. Periodically or with a vacant plant operator position, the Regulatory Manager may be required to work shifts. Therefore, performs operating duties using automated and manual processes; operates pumps, engines, and other process equipment to control flow of sewage and/or water through various processes to ensure plant targets are met as well as compliance with state and federal mandates.
      1. Performs lab analyses and tests on an ongoing basis, according to operating procedures for different processes in the plant;
        1. Collects samples and analyzes results;
        2. Determines appropriate adjustments for chemicals and/or equipment;
        3. Adjusts chemical feed rates, regulates equipment;
      2. Operates pumps, monitors and determines level and flow.
      3. While performing the same or similar work as employees under the line of authority, serves as a team leader, using informed and independent judgment.
      4. Collaborates with the responsible supervisor and recommends performance review content for assigned employees.

    11. Participate in Planning, Master Planning, and Financial Planning efforts by the Water Utility.

    12. Performs other duties and activities as assigned.
    The job requires a Bachelor's degree in engineering, chemistry, environmental chemistry, or a related field and four or more years of experience in the operation of a Water/Wastewater Plant or an industrial facility; or an equivalent combination of education and experience sufficient to successfully perform the essential duties of the job such as those listed above. A valid State of North Dakota Grade 4 Water/Wastewater Plant Operator Certificate is preferred, but not required. A valid driver’s license is also required.

    Knowledge, skills, and abilities include:
    • Knowledge of the Safe Drinking Water Act, Clean Water Act, and National Pollutant Discharge Elimination System (NPDES). 
    • Knowledge of local, state and federal laws, rules and regulations concerning treatment plant operations;
    • Knowledge of the proper operation and maintenance of equipment used in the treatment process including pumps and motors;
    • Knowledge of confined space entry and hazardous materials handling as related to treatment process;
    • Knowledge of procedures of sampling and sample testing;
    • Knowledge of principles of water, wastewater and sludge treatment processes and process control;
    • Skill in organizing and prioritizing work;
    • Skill in providing instruction and training to other workers;
    • Skill in performing mechanical maintenance and repair to equipment;
    • Skill in performing basic mathematical computation such as addition, subtraction, multiplication and division;
    • Skill in reading and writing English sufficient to read and write logs and records;
    • Skill in observation and interpretation of changes in process control to sufficiently determine necessary adjustments;
    • Skill in operation of all plant equipment and in the performance of all operating activities;
    • Skill in mathematical computations and data analysis;
    • Intermediate skill with Microsoft Office applications;
    • Ability to interpret technical manuals and reports:
    • Ability to communicate effectively in both verbal and written forms;
    • Ability to learn water control computer system;
    • Ability to establish and maintain effective working relationships with others.
    Most work is performed in a plant environment. Work is generally heavy and involves moving equipment and bags of chemicals, climbing into basins to clean, climbing ladders up to 25 feet, and moving between buildings and rooms. There is exposure to hazardous chemicals, wet, cold and slippery conditions. Occasional local driving is required.

    Climbing, balancing, stooping, kneeling, crouching, crawling, reaching, standing, walking, pushing, pulling, lifting, digital dexterity, grasping, feeling, talking, hearing/listening, seeing/observing, repetitive motions.

    Heavy Work: Exerting up to 100 pounds of force occasionally, and/or up to 50 pounds of force frequently, and/or up to 20 pounds of force constantly to move objects.

    Some requirements in this job description may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees. All requirements are subject to modification to reasonably accommodate individuals with disabilities.

    Requirements are representative of the minimum levels of knowledge, skills, and experience required. To perform this job successfully, the worker must possess the abilities and aptitudes to perform each duty proficiently.

    This document does not create an employment contract, implied or otherwise, other than an "at will" employment relationship. The City Administrator retains the discretion to add duties or change the duties of this position at any time.
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  • 1025 Amgen GmbH
  • Munich, ND FULL_TIME
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Government Affairs Manager (m / w / d)
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  • Munich, ND FULL_TIME
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Supervisory Wildland Firefighter - Direct Hire Authority.
  • Bureau of Indian Affairs
  • Fort Yates, ND FULL_TIME
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  • 2 Days Ago

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Regulatory Affairs Manager
  • Dental Technologies Inc
  • Lincolnwood, IL
  • Job Description Job Description Job Title: Regulatory Affairs Manager Department: Quality Assurance Reports To: Vice Pre...
  • 6/11/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Catalyst Life Sciences
  • Chicago, IL
  • Opportunity to join a global diagnostics company at their HQ just outside of Chicago, focused on the strategy for existi...
  • 6/10/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Blueroot Health™
  • PURPOSE STATEMENT: This position will be responsible for managing and coordinating implementation of regulatory requirem...
  • 6/10/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Lumicity
  • This opportunity is with a company revolutionizing the medical device industry with its cutting-edge technologies and co...
  • 6/9/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Tandym Group
  • Stamford, CT
  • Top hospital in Fairfield county, CT, just over the border from Westchester county NY, is seeking an experienced Regulat...
  • 6/8/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Mastech Digital
  • Oakland, CA
  • Position: HIM Director-Regulatory Affairs Manager Location: Oakland CA USA 94612 (5 days onsite) Duration: 12+ Months (P...
  • 6/7/2024 12:00:00 AM

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Regulatory Affairs Manager
  • SS White Dental
  • Lakewood, NJ
  • SS White Dental is seeking a Senior Regulatory Affairs Manager to support our Regulatory team. Candidates should have a ...
  • 6/7/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Procter & Gamble
  • Reading, England
  • Job Location Reading Job Description P&G is a leading global consumer goods company whose winning brands are Procter & G...
  • 5/22/2024 12:00:00 AM

North Dakota is a Midwestern state of the United States. It borders Canada and lies at the center of the North American continent. The geographic center of North America is near the town of Rugby. Bismarck is the capital of North Dakota, and Fargo is the largest city. Soil is North Dakota's most precious resource. It is the base of the state's great agricultural wealth. But North Dakota also has enormous mineral resources. These mineral resources include billions of tons of lignite coal. In addition, North Dakota has large oil reserves. Petroleum was discovered in the state in 1951 and quickly...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$137,083 to $193,358

Regulatory Affairs Manager in Wichita Falls, TX
Other names for this job might include Clinical Trials Systems Administrator, Global Regulatory Affairs Manager, Regulatory Administrator, Regulatory Affairs Director, Regulatory Affairs Manager, Regulatory Affairs Portfolio Leader, Regulatory Consultant, Regulatory Leader, Regulatory Process Manager, Regulatory Product Manager.
January 17, 2020
Regulatory Affairs Manager in Baltimore, MD
Lead strategic contributions and initiatives to develop regulatory services and improve current processes and procedures.
January 18, 2020
Regulatory Affairs Manager in Fort Lauderdale, FL
Regulatory Domain Support for business development, including solutioning and developing innovative solutions, creation of materials for and participation in sales pursuits, key client meetings, bid defences for RFIs and RFPs.
December 04, 2019