Senior DoD Regulatory Affairs SME - Drugs, Biologics & Devices
Arcetyp LLC
Arcetyp LLC is seeking a Senior DoD Regulatory Affairs SME to guide regulatory strategy for drugs, biologics, blood products, and medical devices across federal programs. The role is onsite at Fort Detrick, MD and requires leadership in submissions, lifecycle planning, and regulatory interactions with FDA and other agencies. You will mentor cross-functional teams, develop IND/NDAs/PMAs/510(k)s, and drive regulatory excellence for government and commercial clients. #J-18808-Ljbffr Arcetyp LLC
- ...sponsor H1B. Arcetyp LLC is looking for a Senior DoD Regulatory Affairs Specialist - Medical Products. This position is... ...Develop and review regulatory strategies for drugs, biologics, blood products, and medical devices. Prepare/review INDs, NDAs, PMAs, 510(k)s,...SeniorFull timeH1bRemote work
- ...Senior Vaccine and Biologic Development SME | Healthcare and Life Sciences ProSidian Seeks... ...development, manufacture, and regulatory approval/ licensure/... ...diagnostics and other medical devices/infrastructure vaccines... ...Vaccine and Biological Drug Development SME ~ Subject...SeniorFull timeContract workFor contractorsWork at office
- ...Senior Consultant SME The Senior Consultant SME provides expert-level scientific and operational... ...for senior leaders, collaborates with DoD and international partners, and ensures... ...in a relevant scientific field (e.g., Biology, Medical Technology, Chemistry, Hematology...Senior
- ...& Transfusion Medicine SME . This position is onsite... ...FUNCTIONS: Serve as senior SME in blood/blood... ...nonclinical programs, regulatory strategies, CMC, testing... ...product development. FDA biologics/drug/device experience. CMC experience. DoD acquisition lifecycle...SuggestedFull timeH1bRemote work
- LTC Solutions, LLC is hiring a Joint Logistics Capabilities SME to provide mid-level logistics and capability-development support on-site at the Pentagon. You will work with HQMC, LPOV, and other DoD stakeholders to inform logistics modernization through research, analysis...Senior
- SHR Consulting Group is looking for a Senior System Engineer Subject Matter Expert (SME) located in Arlington, VA. This role requires at least 7 years of experience... ...and manage high-availability systems while ensuring compliance with DoD requirements. #J-18808-Ljbffr ADP, Inc.Senior
- ...Defense leads efforts to detect and disrupt drug trafficking and transnational crime that... ...security. Supporting U.S. and partner nations, DoD deploys specialized assets and... ...Friday. Required Clearance: Active TS/SCI Senior Policy Analyst – Program Support The Policy...SeniorTemporary workFor contractorsWork at officeRemote workMonday to FridayFlexible hours
$118k - $170k
...website: JOB OVERVIEW American Oversight seeks a Counsel or Senior Counsel to join our team to lead and support high-impact... ...to $100/month reimbursement for internet services and personal device ~ Professional development stipend ~$400/yr home office stipend...SeniorSummer workInternshipWork at officeLocal areaRemote workHome officeFlexible hoursWeekend workAfternoon shift$100k - $135k
...Job Title Senior Electrical Engineering Technician Location Bethesda, MD 20800 US (Primary) Category Research, Development... ...layout and specific diagrams to construct and package simple devices and subunits of equipment. Conducting various tests or...SeniorFull time- ...Description Mechanical engineers research, develop, design, manufacture, and test tools, engines, machines, and other mechanical devices. They work on power-producing machines such as electric generators, internal combustion engines, and steam and gas turbines....SeniorContract work
- ...sponsor H1B. Arcetyp LLC is looking for a Senior Dod Medical Product Program Manager - Clinical & Regulatory . This position is onsite and located in Fort Detrick... ...protocol/project management. Regulatory affairs and technical documentation. DoD medical...SeniorFull timeH1bRemote work
$145k - $149.15k
...is seeking a highly motivated Senior Systems Engineer to join our... ...operating systems, and attached devices. This role provides day-to-day... ...Subject Matter Expertise (SME) in cloud computing, virtualization... ...and fully understand NIST and DoD security requirements. Our...SeniorFull timeContract workTemporary workLocal area$102k - $127k
Job DescriptionECS is seeking a TS-cleared Senior Information Systems Security Officer (ISSO) to support one of our mission critical programs... ...proficiency aligned to Security Architect (722) of DOD 8140 requirements:Master's Degree in one of the following disciplines...SeniorContract work$110k - $140k
Explosives Safety Subject Matter Expert — Explosive SME Location: Arlington, Virginia with nationwide travel Employment: Full-time;... ...ammunition, or range safety. ~Demonstrated knowledge of Army or DoD explosives-safety requirements. ~Experience evaluating munitions...Full timeContract workRemote work- ...Job Description Job Description Senior DoD Staff Writing SME Job Type: Contractor Location: Remote – United States Job Overview We are seeking experienced Senior DoD Staff Writing SMEs to contribute their expertise to an AI-focused project. The role involves...SeniorRemote jobFor contractors
- ...hardware exploitation and examination of various digital media devices. Conduct reverse engineering, failure analysis, and vulnerability... ...of digital media Serve as a subject matter expert for IC/DOD customers Prepare clear and concise technical reports to a wide...SeniorContract workFor contractorsWork experience placement
- ...Description Xcelerate Solutions is seeking a Senior GPU Platform Engineer to design, develop,... ...as needed. CUDA (Compute Unified Device Architecture) /OpenCL (Open Computing Language... .... ~ Candidate must, at a minimum, meet DoD 8570.11- IAT Level II certification...Senior
$97.96k - $103.11k
...Scheduler For DoD Customer's Classified Network ServicesAbile Group has an exciting and challenging opportunity for a potential Scheduler supporting a DoD Customer's Classified Network Services. The mission will include Operations, Compliance, Cyber Security, Customer...SeniorContract workTemporary workFor contractorsWork experience placementImmediate start$68k - $165k
...Summary Odyssey is looking for a Regulatory Affairs SME 2, to support the Defense Health... ...regulatory affairs for medical products (drugs, biologics, or devices).Other experience:Proven experience... ...), and/or experience working with DoD-sponsored medical product...Full timeContract workTemporary workWork experience placementLive outRemote workFlexible hours$135.62k - $203.44k
...Gaithersburg, MarylandReports to: Senior Director, Global Regulatory Strategy About Alexion For... ...Manager, Regulatory Affairs US lead will be... .... INDs, BLAs/NDAs, orphan drug designation applications,... ...subject areas to turn complex biology into transformative medicines...SeniorFull timeTemporary workWork at office- ...Alluvionic is currently seeking experienced applicants for a Senior Program Analyst/SME position to support the National Science Foundation (NSF),... ...has been nontraditional. Alluvionic is an authorized DoD SkillBridge Partner Organization. The DoD SkillBridge program...SeniorContract workTemporary workInternshipRemote work
$150k - $170k
...solutions supporting critical Federal and DoD missions. We specialize in delivering... ...’re Looking For (Position Overview:) The Senior Policy Analyst provides policy research,... ...alignment with organizational objectives, regulatory requirements, and mission priorities. The...SeniorContract work- .... is seeking an Acquisition Consultant/Sr. Management Analyst in Falls Church, VA to standardize and coordinate information, support DoD programs, and ensure compliance with acquisition policies through timely reporting and documented processes. The role requires a master...Senior
$202.4k - $253k
...progress. About the role: The Senior Counsel, Regulatory provides pragmatic,... ...partners closely with Regulatory Affairs, Insights, Data & Analytics... ...brands. The U.S. Food and Drug Administration has authorized... ...heated tobacco devices and Swedish Match’s General...SeniorFull time- RTX is seeking a Contracts Manager in a hybrid role based in Rosslyn, VA, to support a portfolio of DoD and commercial contracts. You will advise on contract matters, review and negotiate a variety of agreements, and ensure compliance with FAR/DFARS while coordinating with...SeniorContract work
- AV in Arlington, VA seeks a Technical Editor to support proposal development by refining content for clarity, accuracy, and compliance. You will work with proposal managers, writers, and subject matter experts to produce customer-focused, high-quality materials aligned ...Senior
- Systems Planning and Analysis, Inc. (SPA) seeks a Senior Policy Analyst to support Navy Staff at the Pentagon in Arlington, VA. The role... .... The ideal candidate has a Master’s degree, 10+ years of DoD policy experience, and a current DoD Secret clearance. Strong communication...Senior
- ...activities, vulnerability analysis, and incident response support. Qualified candidates will have a BS in CS or related field, 4-7 years in a senior cybersecurity role, DoD 8140.03/DCWF, and an active Top Secret clearance. #J-18808-Ljbffr Bering-Alaka'ina Holdings, LLCSenior
- ...Policy Analyst based in Alexandria, VA. This role requires an Active DoD Top Secret Clearance with SCI eligibility. The ideal candidate... ...in policy analysis, technical support, and communication with senior leaders. The job requires a Bachelor’s degree, along with...Senior
- ...Analysis, Inc. seeks a Sr. Research Analyst to support the JAPEC team, conducting integrated risk assessments and data synthesis for DoD programs. The role requires collaboration with LE/CI, DoD leadership, and onsite client engagement at ARLIS/College Park. Eligible candidates...Senior
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