Regulatory Affairs Director jobs in Wilmington, NC

Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes 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 Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

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Senior Manager, Regulatory Affairs New Plants
  • GE
  • Wilmington, NC OTHER
  • Job Description Summary

    The New Plant/Product (NPP) Licensing Manager will establish the vision & strategy and drive execution for Regulatory Affairs to accelerate the licensing needed to deploy new technologies. Responsible for managing teams and providing leadership and strategic guidance for new plant and product licensing activities in GEH and GNF. Responsible for driving execution across multiple new build projects. Build and mentor a high-performance team that will bring new products/projects to market. Work cross functionally with the product and project managers, engineering and senior management to formulate and execute the strategy. Establish and manage relationships with regulators, customers and industry working groups. Review, approve and submit documents to regulators and industry working groups. Occasional travel is required. The role is in Regulatory Affairs and reports to the General Manager of Nuclear Programs.

    Job Description

    Roles and Responsibilities

    For new plants and new products:

    • Lead the strategic development and deployment for licensing.
    • Drive execution of multiple new build projects to be on schedule and on budget.
    • Establish and maintain effective business relationships with the Nuclear Regulatory Commission (NRC) and non-US nuclear regulators as main point of contact.
    • Provide expert knowledge of the US NRC and non-US nuclear rules and regulations, as appropriate.
    • Provide functional work direction to the licensing engineers and licensing project managers.
    • Monitor applicable nuclear regulations and ensure GEH / GNF manage applicable changes.
    • Maintain nuclear licensing basis documents and correspondence records.
    • Manage periodic and reactive nuclear regulatory inspections/audits.
    • Lead resolution of nuclear licensing / regulatory compliance issues.
    • Coordinate efforts and interfaces of the Regulatory Affairs organization with other GEH / GNF teams.
    • Coordinate interfaces with industry organizations (e.g., NEI and INPO).
    • Manage Licensing staffing and budget.

    Required Qualifications

    • Bachelor’s Degree in engineering or related technical discipline from an accredited university or college.
    • Minimum of 10 years of experience in nuclear regulated design, operations or licensing.
    • At least 5 years of experience in a leadership/management role with significant scope and responsibility.
    • Willingness and ability to travel occasionally.

    ELIGIBILITY REQUIREMENTS: Ability and willingness to obtain and maintain a site security clearance, including NRC required background check.

    The preferred work location is Wilmington, NC but remote will be considered for highly qualified candidates.

    Desired Characteristics

    • Experience working with regulatory, governmental agencies.
    • Working knowledge of 10 CFR Parts 21, 50, 52.
    • Exhibits behaviors in line with strong Nuclear Safety Culture (i.e., respectful work environment / environment for raising concerns).
    • Assesses potential impacts of regulatory landscape on business and customers.
    • International Regulatory Experience is highly preferred.
    • Master's Degree in a Science or Engineering from an accredited university or college preferred.
    • Strong business and financial acumen.
    • Strong interpersonal and leadership skills including facilitation.
    • Ability to work effectively with senior executives.
    • Strong oral and written communication skills.
    • Clear, credible communicator on technical issues.
    • Strong program / project management skills.
    • PC proficiency

    Available health and welfare benefits include healthcare, prescription drug, dental, and vision coverage; savings account options (such as a Health Care Flexible Savings Account, Health Reimbursement Account, Limited Purpose Flexible Spending Account, and Dependent Care Flexible Spending Account); and an employee assistance program. Additional benefits include a defined contribution 401(k) plan, employee life insurance, optional dependent life insurance, employee accidental death or dismemberment insurance coverage, salary continuance program benefits for disability, optional long-term disability, pre-tax transportation/commuter program, paid holidays, paid time off, parental leave, a layoff plan for salaried employees, tuition reimbursement program, use of Cariloop, adoption assistance, optional identity theft prevention insurance, optional personal legal assistance, and optional personal excess liability insurance.

    This role requires access to U.S. export-controlled information. If applicable, final offers will be contingent on ability to obtain authorization for access to U.S. export-controlled information from the U.S. Government.

    Additional Information

    GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

    GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

    Relocation Assistance Provided: Yes

  • 4 Days Ago

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Director of Resource Management for Business Affairs and Chancellor Divisions
  • University of North Carolina Wilmington
  • Wilmington, NC FULL_TIME
  • Posting Details Benefits of Working at UNCW Want to become a soaring UNCW Seahawk and work at one of the best universities on the East Coast? Want to put your toes in the sand after a day of work? The...
  • 25 Days Ago

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Director
  • Cape Fear Gospel Rescue Mission
  • Wilmington, NC FULL_TIME
  • The Cape Fear Gospel Rescue Mission has an opening for the position of Director. The selected candidate should have experience in the following areas: Understanding and support of Twelve Step recovery...
  • 13 Days Ago

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Director of Marketing
  • Century Care Management
  • Morehead, NC FULL_TIME
  • BASIC PURPOSE: Crystal Bluffs is looking for a Director of Marketing to join our team! The purpose of the Director of Marketing is to maintain relationships and communicate with the stakeholders to in...
  • 15 Days Ago

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Director of Nursing
  • Cornelia's Restaurant
  • Wilmington, NC FULL_TIME
  • Overview:We are seeking a highly skilled and experienced Director of Nursing to join our team. As the Director of Nursing, you will be responsible for overseeing the nursing department and ensuring th...
  • 15 Days Ago

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Maintenance Director
  • Brunswick Health and Rehabilitation
  • Calabash, NC FULL_TIME
  • We are a leader in the long-term care industry operating in 6 different states. It is our commitment to the care of our residents and our staff that sets us apart from the rest. From the development o...
  • 16 Days Ago

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0 Regulatory Affairs Director jobs found in Wilmington, NC area

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Lead and Copper Regional Lead-Charlotte,NC
  • Black & Veatch
  • Wilmington, NC
  • **Lead and Copper Regional Lead-Charlotte,NC**Date: Mar 27, 2024Location:Charlotte, TX, US USCompany: Black & Veatch Fam...
  • 4/23/2024 12:00:00 AM

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Director Biostatistics
  • PharPoint Research, Inc.
  • Wilmington, NC
  • Summary: We are currently seeking a Director, Biostatistics to join our growing team. In this role you will develop and ...
  • 4/22/2024 12:00:00 AM

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Project Director, Safety Governance
  • AbbVie
  • Carolina Beach, NC
  • Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious he...
  • 4/21/2024 12:00:00 AM

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Water Plant Superintendent
  • Pender County, NC
  • Burgaw, NC
  • Salary: $62,274.11 - $93,411.17 Annually Location : 605 Fremont Street Burgaw Job Type: Full-Time Permanent Job Number: ...
  • 4/21/2024 12:00:00 AM

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RN - Operating Room -FT
  • Wilmington SurgCare
  • Wilmington, NC
  • Job Summary: The Operating Room Registered Nurse, under the supervision of the OR Manager or the Director of Nursing and...
  • 3/27/2024 12:00:00 AM

Wilmington is a port city and the county seat of New Hanover County in coastal southeastern North Carolina, United States. With a population of 119,045 in 2017, it is the eighth most populous city in the state. Wilmington is the principal city of the Wilmington Metropolitan Statistical Area, a metropolitan area that includes New Hanover and Pender counties in southeastern North Carolina, which has a population of 263,429 as of the 2012 Census Estimate. Wilmington was settled by the English along the Cape Fear River. The city was named after Spencer Compton who was the Earl of Wilmington. Its ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$154,828 to $220,511
Wilmington, North Carolina area prices
were up 1.5% from a year ago

Regulatory Affairs Director in Spartanburg, SC
There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful.
December 13, 2019
Regulatory Affairs Director in New Brunswick, NJ
The apprenticeship programme lasts 30 months and provides a combination of Masters-level training in regulatory affairs and paid work experience.
February 12, 2020
Regulatory Affairs Director in Syracuse, NY
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
January 18, 2020