We have other current jobs related to this field that you can find below

  • Professional Nursing Specialist

    14 hours ago

    Eglin Air Force Base, Florida, United States Department of Veterans Affairs Full time

    Registered NurseOverviewThis role is part of the Education Debt Reduction Program (EDRP), which offers a reimbursement initiative for student loan payments. Applicants must fulfill specific eligibility criteria as outlined by VHA policy and submit their EDRP application within four months of their appointment. Approval, award amounts (up to $200,000), and...

  • Acquisition Strategy Specialist

    16 hours ago

    Hanscom Air Force Base, United States Abacus Technology Corporation Full time

    Position OverviewAbacus Technology Corporation is in search of an Acquisition Strategy and Documentation Subject Matter Expert (SME) to deliver acquisition assistance for the Command, Control, Communication, Intelligence and Networks (C3I&N) Directorate. This is a full-time opportunity.Key ResponsibilitiesConduct planning, research, analysis, and evaluation...

  • Acquisition Strategy Specialist

    2 days ago

    Hanscom Air Force Base, United States Abacus Technology Corporation Full time

    Position OverviewAbacus Technology Corporation is in search of an Acquisition Strategy and Documentation Subject Matter Expert (SME) to deliver acquisition assistance for the Command, Control, Communication, Intelligence and Networks (C3I&N) Directorate. This role is a full-time commitment.Key ResponsibilitiesConduct planning, research, analysis, and...

  • Program Integration Specialist

    6 days ago

    Hanscom Air Force Base, United States Abacus Technology Corporation Full time

    Position OverviewAbacus Technology Corporation is in search of a Program Integration Subject Matter Expert (SME) to contribute to the advancement of cutting-edge technology solutions tailored to meet the operational requirements of the warfighter, specifically in the realms of electronic and cyber warfare for the USAF Lifecycle Management Center (AFLCMC)....

  • Program Integration Specialist

    18 hours ago

    Hanscom Air Force Base, United States Abacus Technology Corporation Full time

    Position OverviewAbacus Technology Corporation is looking for a Program Integration Subject Matter Expert (SME) to contribute to the creation of innovative, advanced technological solutions tailored to the needs of the warfighter, specifically in the domains of electronic and cyber warfare for the USAF Lifecycle Management Center (AFLCMC). This is a...

  • it specialist

    3 weeks ago

    Scott Air Force Base, Illinois, United States Air Force Elements, U.S. Transportation Command Full time

    This position is being filled under the memorandum from the Under Secretary of Defense for Personnel and Readiness (USD(P&R)) "Expansion of Direct Hire Authority for Certain Personnel of the Department of Defense," dated October 15, 2021.This position is being filled under AcqDemo Direct Hiring Authority (DHA) for non-acquisition positions involving 51% or...

  • it specialist

    3 weeks ago

    Scott Air Force Base, Illinois, United States Air Force Elements, U.S. Transportation Command Full time

    This position is being filled under the memorandum from the Under Secretary of Defense for Personnel and Readiness (USD(P&R)) "Expansion of Direct Hire Authority for Certain Personnel of the Department of Defense," dated October 15, 2021.This position is being filled under AcqDemo Direct Hiring Authority (DHA) for non-acquisition positions involving 51% or...

  • Environmental Regulatory Coordinator

    6 days ago

    Kirtland Air Force Base, United States ASRC Federal Holding Company Full time

    Job Overview ASRC Federal Holding Company is in search of an Environmental Specialist to contribute to environmental compliance initiatives under a significant engineering operations contract. Key Responsibilities:Ensure thorough documentation and technical execution of environmental processes in accordance with NEPA and local regulations.Evaluate and manage...

  • Sports Nutrition Specialist

    11 hours ago

    Holloman Air Force Base, New Mexico, United States Bering Straits Native Corporation (BSNC) Full time

    Position Overview:Bering Straits Native Corporation (BSNC) is seeking a qualified Performance Dietitian to enhance the Human Performance Program. This role is pivotal in supporting military personnel at a state-of-the-art facility dedicated to human performance.Key Responsibilities:Implement nutrition policies and program requirements as per established...

  • Clinical Nurse Specialist

    6 days ago

    Eglin Air Force Base, Florida, United States Department of Veterans Affairs Full time

    Registered NursePosition OverviewThis role is part of the Education Debt Reduction Program (EDRP), which offers reimbursement for student loan payments. Eligibility requirements must be met in accordance with VHA policy, and the EDRP application should be submitted within four months of appointment. Approval, award amounts (up to $200,000), and eligibility...

  • Information Assurance/Security Specialist

    3 months ago

    Eglin Air Force Base, United States Isys Technologies Full time

    Minimum Clearance Required: Top Secret SCI Responsibilities: I2X Technologies is a reputable technology services company to the Federal Government. Whether the focus is on space exploration, national security, cyber security, or cutting-edge engineering applications, I2X is ready to offer you the chance to make a real-world impact in your field and for your...

  • Information Technology Specialist

    5 days ago

    Scott Air Force Base, Illinois, United States Air Force Elements, U.S. Transportation Command Full time

    Position OverviewThis role is integral to the Department of Defense (DoD) Acquisition Workforce Personnel Demonstration Project (AcqDemo), specifically within the Air Force Elements of the U.S. Transportation Command.Key ResponsibilitiesThis position is filled under the Direct Hire Authority (DHA) for non-acquisition roles that support acquisition functions....

  • Information Technology Specialist

    6 days ago

    Scott Air Force Base, Illinois, United States Air Force Elements, U.S. Transportation Command Full time

    Position OverviewThis role is situated within the Department of Defense (DoD) Acquisition Workforce Personnel Demonstration Project (AcqDemo), specifically supporting the Air Force Elements of the U.S. Transportation Command.Key ResponsibilitiesThis position is being filled under the Direct Hire Authority (DHA) for non-acquisition roles that require a...

  • Senior Electrical Avionics Specialist

    17 hours ago

    Whiteman Air Force Base, Missouri, United States Northrop Grumman Full time

    Requisition ID: R At Northrop Grumman, our workforce enjoys remarkable opportunities to engage in groundbreaking systems that influence lives globally, both now and in the future. Our innovative and creative ethos has positioned us at the forefront of numerous technological milestones in our nation's history - from pioneering transatlantic flights to...

  • Healthcare Coordinator

    3 weeks ago

    Fairchild Air Force Base, United States JVM Solutions Full time

    Job DescriptionJob DescriptionJohnson Venture Management Solutions is hiring a Healthcare Coordinator at the Fairchild Air Force Base in Washington.The Healthcare Coordinator will counsel active duty and reserve component members on the program requirements, military benefits, legal rights, and the appeals process in support to the 92nd Medical Group Medical...

  • Environmental Technician

    3 months ago

    Eielson Air Force Base, United States Environmental Compliance Consultants Full time

    Job DescriptionJob DescriptionDescription:Environmental Compliance Consultants inc. (ECC) offers an exciting opportunity to pursue or continue a career in environmental and industrial services as an Environmental Technician. With 25 years in the industry, we are a leading provider of environmental services to our local communities, the Department of Defense,...

  • Security Operations Specialist

    6 days ago

    Edwards Air Force Base, California, United States Lockheed Martin Full time

    Position Overview:Join Lockheed Martin Aeronautics, a leader in advanced technology and defense systems, as we seek a dedicated professional to enhance our Security and Emergency Services (SES) Team. This role is pivotal in safeguarding our personnel and assets while ensuring adherence to U.S. government security protocols.Key Responsibilities:Document...

  • Sustainability Compliance Coordinator

    6 days ago

    Charleston Air Force Base, United States Air Mobility Command Full time

    SummaryJoin the Air Mobility Command as a vital member of our environmental team. This role focuses on providing administrative support, enhancing, and overseeing various environmental initiatives under the mentorship of experienced environmental protection specialists. The position involves conducting specialized fieldwork and assisting environmental...

  • Military Financial Guidance Specialist

    6 days ago

    Malmstrom Air Force Base, United States Magellan Health Full time

    Position OverviewThis role is designed to provide immediate support during critical times, addressing the financial needs of military personnel and their families. The primary focus is on delivering comprehensive personal finance counseling services at military locations.Key Responsibilities- Deliver personalized financial management and counseling services...

  • Security Program Manager

    6 days ago

    Nellis Air Force Base, Nevada, United States Huntington Ingalls Industries Full time

    Requisition Number: 19100Required Travel: 0 - 10%Employment Type: Full Time/Salaried/ExemptAnticipated Salary Range: $70,000 - $105,000.00Security Clearance: TS/SCILevel of Experience: MidThis opportunity is with Live, Virtual, Constructive Solutions, a segment within HII's Mission Technologies division. As a reliable partner to our military clientele, we...

Regulatory Affairs Specialist

3 months ago

Hanscom Air Force Base, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Prepares regulatory strategies and maintains submissions for U.S. and International markets, including but not limited to 510(k)s and Technical Files, to ensure timely approval of devices and continued regulatory support of marketed devices.
  • Reviews and summarizes post-market surveillance feedback, such as customer feedback, adverse event reporting, customer surveys, trade shows, and publications.
  • Evaluates and documents all alleged reportable events and field action reviews/assessments. Prepares and submits all MDRs and associated documentation to the FDA and adverse event reports to other countries within the required timeframes. Follows-up, as required, for failure investigations associated with reportable events. Interacts with the FDA and other regulatory authorities on all MDR or reportable events.
Requirements:
  • Bachelor of Science degree in a relevant discipline required.
  • Minimum 5 years of experience in medical device Regulatory Affairs with RAC certification or 3 years of experience w/o certification.
  • Strong pre-market regulatory experience particularly in the international pre-market arena (example: EU MDR Tech File submissions)
  • Demonstrated knowledge of FDA QSR, ISO 13485, MDD, MDR, Health Canada, and other applicable U.S. and International regulations, including experience auditing these requirements.
  • Knowledge of Japanese, Australian, and Brazilian requirements preferred.
  • Demonstrated knowledge of ISO 14971 and ISO 10993.
  • Experience with preparing and filing reportable events (MDRs) and Vigilance Reports.
  • Previous experience with FDA regulatory submissions and CE marking.
  • Experience interacting with regulatory bodies, such as the FDA and Notified Body.
  • Experience with the Biocompatibility testing process preferred.