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.
NewSenior Staff Specialist, Regulatory Affairs Apidel TechnologiesSenior Staff Specialist, Regulatory AffairsMemphis, TNContractorSupport for the Regulatory Actions associated with a Legal Manufacturer address change.
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.
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 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.
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).
Clinical Supervisor - Lowell Northeast Health ServicesClinical Supervisor - LowellLowell, MA$51–$62 / hourFull timeJoin us at Northeast Health Services, a member of Transformations Care Network (TCN), as we embark on an exciting journey to empower Clinical Supervisors like you to make a difference in the field of behavioral health. Clinical Supervisors are responsible for providing clinical supervision and training for unlicensed, graduate level clinicians who provide outpatient mental health counseling, along with carrying a caseload.
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.
QMS Document Control & Training Specialist Bioventus LLCQMS Document Control & Training SpecialistMemphis, TNFull timeCollaborates 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.
Regulatory Affairs Lead Napakiak VenturesRegulatory Affairs LeadOak Ridge, TennesseeNapakiak 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.
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.
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.
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.
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.
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.
Research Regulatory Coordinator Tennessee OncologyResearch Regulatory CoordinatorNashville, TennesseeServing as a key liaison between investigators, research teams, sponsors, Institutional Review Boards (IRBs), and regulatory agencies, the Research Regulatory Coordinator facilitates efficient communication, submission processes, and regulatory approvals across the site network. Collaborates with investigators, study coordinators, sponsors, CROs, IRBs, and institutional departments to facilitate study activation, ongoing compliance, and successful study close-out activities across a portfolio of oncology clinical trials.
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.
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.
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.
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.