NewRegulatory Manager PrinovaRegulatory ManagerSpring Hill, TennesseeMain Duties & ResponsibilitiesEnsure compliance with established regulations and customer requirements, including GMPs as listed in 21 CFR 111 and 117, and Global Food Safety Initiative (GFSI) scheme; Work with R&D and customers to create compliant labels; Proofread and review label content (includes building and inbound review process); Oversee the creation of manufacturing documentation; Work with regulatory agencies to gather documentation and regulatory certificates; Set up internal procedures to certify products with regulatory agencies; Manage label revisions internally and develop a tracking process for label inventory; Manage manufacturing documentation revisions, including change control and deviations; Complete final review and approval of product specifications, production batch records, laboratory raw data, labels, and COAs for raw materials and finished products; Support internal audits to ensure policies and regulations of FDA (cGMP), TDA, third party certifiers and internal SOPs are followed; Maintain and monitor Quality System Programs (Non-Conformance, Internal Audit, training, etc.) to ensure food safety and quality requirements are met; Interface with outside governmental agencies, such as: USDA, FDA, TDA, etc., 3rd party auditors such as: BRC, QAI, OU, etc., and to consumers and customers through investigation and response to complaints; Interface with customers for their audit requirements of our production facilities; Monitor and maintain the Supplier Qualification Program; Ensure products are compliant based on final delivery form and region of distribution; Write regulatory processes and work with Quality Management to develop new quality processes; Follow cGMP guidelines and processes as established in department SOPs; Meet goals and objectives as outlined by the Executive Management team; Perform other duties as deemed necessary. Demonstrated leadership and team management skills; Experience in motivating teams and team building; Willing to work closely with a team and develop processes and team members; Knowledge of label compliance requirements; Experience working at a cGMP facility, experience working with NSF preferable; Experience working with outside regulatory agencies; Writing and/or technical writing skills, experience writing SOPs; Detail oriented and highly organized; Excellent written and oral communication skills; Working knowledge of ERP Systems, LIMS, Microsoft office and general computer concepts; Intermediate math, communication, and problem solving skills; Strong documentation practices and record keeping skills; Ability to follow company processes and procedures; Ability to work without direct supervision.
Regulatory Affairs Manager (Transplant Diagnostics) Thermo Fisher Scientific IncRegulatory Affairs Manager (Transplant Diagnostics)TNWe provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Working closely with cross-functional teams, you'll help develop and implement regulatory strategies that enable the successful commercialization of our advanced products, from initial planning through post-market activities.
Product Compliance Regulatory Manager, Operations Highline-WarrenProduct Compliance Regulatory Manager, OperationsMemphis, TNWhile performing auditing duties at manufacturing and distribution facilities, the individual may be exposed to hazardous physical or chemical conditions, including mechanical parts, electrical currents, vibrations, fumes, odors, dust, gas, poor ventilation, extreme temperatures, and intense noise. The Product Compliance Regulatory Manager, Operations is also responsible for exercising independent judgment and discretion when performing all his/her job duties including with respect to mentoring, developing, and managing direct reports and other Product Compliance team members.
Product Compliance Regulatory Manager, Operations Highline WarrenProduct Compliance Regulatory Manager, OperationsMemphis, TNWhile performing auditing duties at manufacturing and distribution facilities, the individual may be exposed to hazardous physical or chemical conditions, including mechanical parts, electrical currents, vibrations, fumes, odors, dust, gas, poor ventilation, extreme temperatures, and intense noise. The Product Compliance Regulatory Manager, Operations is also responsible for exercising independent judgment and discretion when performing all his/her job duties including with respect to mentoring, developing, and managing direct reports and other Product Compliance team members.
NewSenior Regulatory Affairs Manager Medtronic plcSenior Regulatory Affairs ManagerMemphis, TNThe following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
Senior Regulatory Affairs Manager Medtronic PlcSenior Regulatory Affairs ManagerMemphis, TNp>The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
NewSenior Regulatory Affairs Manager MedtronicSenior Regulatory Affairs ManagerMemphis, TNThe following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here ( a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
Regulatory Affairs Manager Dentsply Sirona IncRegulatory Affairs ManagerJohnson City, TNDentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. This role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance.
Quality, Safety & Regulatory Manager Vanguard SoapQuality, Safety & Regulatory ManagerMemphis, TNFull timeThe Quality, Safety and Regulatory Manager is a key operational leader responsible for ensuring Vanguard Soap consistently delivers safe, high-quality, regulatory compliant products and processes at scale. The role is critical in building a best-in-class Quality and Safety Management System while fostering a culture where quality and safety are owned at every level.
NewDirector, Regulatory Affairs and Compliance Pilot Travel Centers LLCDirector, Regulatory Affairs and ComplianceKnoxville, TNPilot Company supports a growing portfolio of brands with expertise in supply chain and retail operations, logistics and transportation, technology and digital innovation, construction, maintenance, human resources, finance, sales and marketing. Pilot Company is an industry-leading network of travel centers with more than 30,000 team members and over 750 retail and fueling locations in 44 states and six Canadian provinces.
Regulatory Affairs Lead Napakiak VenturesRegulatory Affairs LeadOAK RIDGE, TNFull timeNapakiak Environmental and Construction (NEC) is a leading provider of information technology, technology development, and environmental and construction services, specializing in Federal and Commercial projects. The Regulatory Affairs Lead will lead interactions with regulatory agencies, coordinate safety and environmental compliance activities, and provide strategic guidance on regulatory issues.
Global Manager, Distribution & Sterilization Quality Hollister IncGlobal Manager, Distribution & Sterilization QualityTN$99,000–$141,000 / yearThe role partners closely with Operations, Quality, Supply Chain, Sterilization, and Regulatory Affairs to manage risk, ensure audit readiness, and continuously improve distribution and post‑sterilization quality processes across the global network. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.
Pharmacovigilance Operations Manager Revance Therapeutics IncPharmacovigilance Operations ManagerNashville, TNKey Responsibilities: Leads global Patient Safety Operations and effectively manages select safety surveillance projects for multiple product categories, including prescription drugs, class I, II, and III medical devices, OTC drugs, and cosmetics. Monitors and identifies possible trends and concerns related to the use of Revance products, and key competitor products, including the identification and evaluation of safety signals through the assessment of single case reports, aggregate safety reports and review of relevant literature for safety information pertinent to product safety.
Senior Manager, Digital Delivery Revance Therapeutics IncSenior Manager, Digital DeliveryNashville, TNRemoteli>Lead the end-to-end delivery of digital initiatives across multiple web properties and marketing automation platforms, including omnichannel campaigns, website enhancements, content updates, landing pages, and Salesforce Marketing Cloud (SFMC) journeys. The position combines operational leadership, stakeholder management, and project delivery, overseeing high-volume, multi-channel initiatives while directly managing the Web and Marketing Automation team.
NewNorth America Regional Product Manager (Protein Diagnostics) Thermo Fisher Scientific IncNorth America Regional Product Manager (Protein Diagnostics)TN$113,500–$151,300 / yearPartnering closely with Global Product Management, Commercial Leadership, Regional Marketing, Medical & Scientific Affairs, Market Access, Supply Chain, Regulatory Affairs, Quality, Technical Support, and Field Applications, the Regional Product Manager drives revenue growth, market share expansion, and customer satisfaction. The Regional Product Manager leads complex cross-functional initiatives, influences senior stakeholders, and identifies opportunities to accelerate growth, increase product adoption, and improve portfolio performance across North America.
Senior Program Manager Smith & Nephew PlcSenior Program ManagerMemphis, TNLeading large and complex new product development and product platform programs from ideation through commercialization across Orthopedics portfolios including Hips, Knees, Shoulders, Trauma and Extremities. Based in Memphis, TN, this role offers the opportunity to lead complex, global development programs, influence cross functional teams and shape how we deliver life changing solutions for patients around the world.
Manager, Industry Solutions, Veeva Life Science Deloitte Touche Tohmatsu LtdManager, Industry Solutions, Veeva Life ScienceHermitage, TN$144,200–$265,600 / yearThe wage range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities.
Regulatory Supervisor The Vincit GroupRegulatory SupervisorChattanooga, TennesseeThe Regulatory Supervisor is responsible for preparing, amending, and maintaining product registration for all product categories within our chemical manufacturing division and staying up to date with regulatory changes. This role works closely with the Technical Services, ZEE Sales organization and Vincit ERP support to ensure accuracy and compliance.
Life Science Veeva Senior Manager Deloitte Touche Tohmatsu LtdLife Science Veeva Senior ManagerNashville, TN$189,200–$372,900 / yearThe wage range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities.
Research Study Manager - Center for Digital Health & Optimization - UTK University of Tennessee SystemResearch Study Manager - Center for Digital Health & Optimization - UTKKnoxville, TNSpecific responsibilities include providing a cohesive, collaborative, and mutually supportive environment to support and enhance the quality, quantity and timeliness of service to the research projects; assigning project responsibilities to other research staff; overseeing the successful and timely execution of activities in order to achieve not only the project goals but also the goals of the principal investigator, center and the department. The university holds the highest Carnegie classification for research activity and has deep partnerships with industry leaders and the US Department of Energy's largest multidisciplinary laboratory, Oak Ridge National Laboratory.
Life Sciences Supply Chain and Operations - Supply Chain Planning Manager Accenture PlcLife Sciences Supply Chain and Operations - Supply Chain Planning ManagerNashville, TNAs part of working with clients you will help with several aspects of life sciences integrated planning including: Integrated Planning Strategy: Design and implement IBP/S&OP frameworks tailored to life sciences environments, accounting for regulatory release cycles, CMO/CDMO network complexity, and the distinct planning dynamics of biopharma and med tech product portfolios. Accenture is a leading solutions and services company that helps the world's leading enterprises reinvent by building their digital core and unleashing the power of AI to create value at speed across the enterprise, bringing together the talent of our approximately 786,000 people, our proprietary assets and platforms, and deep ecosystem relationships.
Data Integration Manager X Energy LLCData Integration ManagerOak Ridge, TN$135,000–$160,000 / yearThis role ensures integrations remain compliant with Nuclear Regulatory Commission (NRC), Department of Energy (DOE), International Traffic in Arms Regulations (ITAR), Nuclear Quality Assurance Level 1 (NQA-1), and related regulatory frameworks while supporting reliable fuel manufacturing operations. This role is responsible for the delivery and documentation of Enterprise Resource Planning (ERP) and non-ERP integrations, master data flows, and the interfaces supporting fuel fabrication operations.
Regulatory Affairs Specialist Dentsply Sirona IncRegulatory Affairs SpecialistTNDentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Key Responsibilities: Prepares and submits international regulatory submissions to obtain and maintain regulatory approvals for medical devices, including 510(k) submissions and technical files for CE Marking.
Associate General Counsel, Regulatory Affairs Jackson National Life Insurance CoAssociate General Counsel, Regulatory AffairsNashville, TNThe AGC coordinates regulatory interactions and examinations for Jackson's insurance and distribution businesses; oversees regulatory filings and other regulatory submissions; facilitates remediation of exam findings; provides leadership with regulatory examinations and interactions; assists with highly confidential projects; assists with the development and implementation of corporate policies; and coordinates legal and compliance efforts related to artificial intelligence, data governance, privacy, and social media. Assists in the implementation and management of remediating items identified by regulators as either formal findings or potential issues arising from exams or identified internally by the Jackson Chief Compliance Officer.
Director, Academic Affairs - Remote based in US Other ExecutiveDirector, Academic Affairs - Remote based in USNashville, TNRemote$140–$180 / yearThis position ensures that Tenet Health Hospitals provide a structured, safe and conducive learning environment for our academic affairs which includes Undergraduate Medical Education (UME), Continuing Medical Education (CME), and Clinical Research. Provide direct oversight of multi-site clinical research operations, including research administration, study start-up, regulatory affairs, quality assurance, budgeting, contracting, and patient recruitment.
6Q02 - Quality - QAEN - QUALITY ASSURANCE ENGINEER Inteplast Group Corp6Q02 - Quality - QAEN - QUALITY ASSURANCE ENGINEERTNPOSITION OBJECTIVE: Assists the Quality Assurance and Regulatory Affairs Manager in regulatory compliant company-wide quality assurance department that provides all research, support, product development, and quality assurance functions required along with accurate specifications, service, and delivery of product to our customers. Associate's degree or equivalent from an accredited two-year college/technical school, or higher will be considered, plus 2-4 years of quality assurance engineering experience in a medical device manufacturing environment; or equivalent combination of education and experience.
Director, Rates & Regulatory American Water Works Co IncDirector, Rates & RegulatoryChattanooga, TNDetailed understanding of automatic adjustment mechanisms policies, procedures, and concepts, including items such as surcharge mechanisms, automatic adjustment mechanisms, Balancing Accounts, conservation rates, decoupling, declining consumption, consolidated taxes and creative recovery on significant source of supply projects, to recover actual cost of service. Provides Rates and Regulatory leadership and drives results across the State: Shapes, drives and influences rate case, clause mechanism, and regulatory strategy and policy in collaboration with State, and functional leadership teams and other functions.
Managed Services Sr. Consultant Deloitte Touche Tohmatsu LtdManaged Services Sr. ConsultantTN$120,200–$140,000 / yearLead and contribute to end-to-end delivery for Generis CARA and associated regulatory technology platforms - including requirements gathering, solution design, system configuration, content template development, and user acceptance testing. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities.
Quality Assurance Lead Bureau Veritas SAQuality Assurance LeadKnoxville, TN$75,000–$90,000 / yearCompensation Range: $75,000 - $90,000 annually (e.g., the job posting is not necessarily reflective of actual compensation that may be earned, and actual compensation is subject to variation due to such factors as locations, education, experience, and skillset). Lead customer audits independently, and support QA Manager for regulatory inspections & agency visits.
Program Director, Enrichment Operations BWX Technologies IncProgram Director, Enrichment OperationsOak Ridge, TN$136,000–$207,000 / yearBWX Technologies, Inc. and its affiliates and subsidiaries (BWXT) is not responsible for and does not accept any liability for fees or other costs associated with resumes or candidates presented by recruiters or employment agencies, unless a binding, written recruitment agreement between BWXT and the recruiter or agency exists prior to the presentation of candidates or resumes to BWXT and includes the specific services, job openings, and fees to be paid ("Agreement"). This position serves as an extension of the Presidents office, coordinating activities across Operations, Engineering, Maintenance, Supply Chain, Quality, Regulatory Affairs, Finance, Human Resources, and Capital Projects to ensure organizational priorities are effectively planned, communicated, executed, and monitored.
QMS Documentation & Training Analyst Bioventus IncQMS Documentation & Training AnalystMemphis, TNli>Collaborates with cross-functional teams, including subject matter experts (SMEs), project managers, quality assurance professionals, and regulatory affairs specialists, to gather information, review documents, and facilitate document approvals and revisions. Establishes and maintains document control processes, including version control, document tracking, distribution, and archival, and retention to ensure that documents are current, accessible, and responsibly managed throughout their lifecycle.
Director - Product Security LivaNova PlcDirector - Product SecurityNashville, TNRemote$185,000–$225,000 / yearKey Responsibilities: Strategic Leadership & Program Management: • Define and execute a comprehensive product security strategy that aligns with business priorities, FDA/MDR/524B expectations, and Quality Management System (QMS) requirements. • Manage the generation and maintenance of SBOMs and VEX (Vulnerability Exploitability eXchange) documents to ensure transparency and enable targeted, actionable risk management for regulators and customers.
Regulatory Support Engineer NANA Regional Corporation IncRegulatory Support EngineerOak Ridge, TNWorking under the direction of the Regulatory Support Lead, this role interfaces with nuclear safety staff, engineers, environmental specialists, and project stakeholders to ensure regulatory requirements are clearly interpreted, documented, tracked, and implemented. Education and Experience: BS degree in nuclear engineering, mechanical engineering, engineering science, or a related technical field with 5+ years of relevant experience (or MS with 3+ years, PhD with 1+ years).
NewLicensing Engineer Energy - Remote AtkinsRealis Group IncLicensing Engineer Energy - RemoteOak Ridge, TNRemote$72,000–$120,000 / yearNote to staffing and direct hire agencies: In the event a recruiter or agency who is not on our preferred supplier list submits a resume/candidate to anyone in the company, AtkinsRéalis family of companies, we explicitly reserve the right to recruit and hire the candidate(s) at our discretion and without any financial obligation to the recruiter or agency. Part of the ARUSN Licensing group and will work preparing licensing documentation, such as topical and technical reports, Safety Analysis Reports, and applications for certifications, permits, and licenses.
Veeva Vault Product Owner Accenture PlcVeeva Vault Product OwnerNashville, TNYou are expected to be a subject matter expert, collaborate and manage the team to perform effectively, take responsibility for team decisions, engage with multiple teams, contribute to key decisions, and provide solutions to problems within your immediate team and across multiple teams. The Advanced Technology Centers (ATCs) make tremendous impact in solving our clients' business problems leveraging Innovation, Intelligence, Industry insights, new IT and new technology skills.