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
- ...not accept corp-to-corp (C2C) candidates. We can't sponsor H1B. Arcetyp LLC is looking for a Senior DoD Regulatory Affairs SME – Drugs, Biologics & Medical Devices . This position is onsite and located in Fort Detrick, MD. ESSENTIAL JOB FUNCTIONS: Serve as...SeniorFull timeH1bRemote work
- Arcetyp LLC is seeking a Senior DoD Regulatory Affairs SME - Drugs, Biologics & Medical Devices for an onsite role in Fort Detrick, MD. You will lead regulatory strategies, submissions, and agency interactions to support military, DoD, and commercial programs. Responsibilities...Suggested
- Arcetyp LLC is seeking a Senior DoD Regulatory Affairs Specialist - Medical Products for an onsite role in Fort Detrick, MD... ...focuses on regulatory strategy across drugs, biologics, blood products, and medical devices, with responsibilities including IND/NDAs/PMAs...Senior
- ...'t 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, technical...SeniorFull timeH1bRemote work
- Arcetyp LLC is seeking a Senior DoD Regulatory Affairs Specialist - Medical Products for an onsite role in Fort Detrick, MD... ...develop and review regulatory strategies for drugs, biologics, blood products, and medical devices, and prepare or review INDs, NDAs, PMAs, 510(k...Senior
- ...DescriptionProSidian Seeks a Senior Vaccine and Biologic Development SME | Healthcare and Life... ...development, manufacture, and regulatory approval/ licensure/... ...diagnostics and other medical devices/infrastructure vaccines... ...Vaccine and Biological Drug Development SMESubject...SeniorFull timeContract workTemporary workFor contractorsWork at officeFlexible hours
- ...DescriptionProSidian Seeks a Senior Drug/Vaccine/Diagnostic... ...Development SME | Healthcare and... ...of chemical, biological, radiological, and... ...manufacture, and regulatory approval/ licensure... ...and other medical devices/infrastructure vaccines... ...in regulatory affairs, including preparing...SeniorFull timeContract workTemporary workFor contractorsWork at officeFlexible hours
$116.35k - $210.33k
...reliable communications for the Department of Defense (DoD) and Combatant Commands (COCOMs).Leidos is seeking a Senior Windows Systems Administrator (SA) to serve as the primary Windows SA and subject matter expert (SME) for our team. This role focuses on ownership of our...SeniorPermanent employmentFull time- ...Consulting at DescriptionProSidian Seeks a Senior Regulatory Affairs SME | Healthcare and Life Sciences [HHS1... ...medical consequences of chemical, biological, radiological, and nuclear (CBRN)... ...to diagnostics and other medical devices/infrastructure vaccines and other preventives...SeniorFull timeContract workTemporary workFor contractorsWork at officeFlexible hours
- ...DescriptionProSidian Seeks a Vaccine and Biologic Development SME | Healthcare and Life... ..., manufacture, and regulatory approval/ licensure/ clearance... ...and other medical devices/infrastructure vaccines and... ...in vaccine and biological drug development, particularly in...Full timeContract workTemporary workFor contractorsWork at officeFlexible hours
- LMI seeks a Senior Audit Readiness Subject Matter Expert to support OASW(Sustainment) in ensuring compliance and governance for DoW asset and financial management. The role focuses on audit readiness, asset data integration, and end-to-end reporting across DAF/DoN/DLA...Senior
$125.3k - $233k
Secure Space Technical and Physical Security SME, Senior ManagerThe Opportunity:This position serves as the Subject Matter Expert within the... ...for a portfolio of SCIFs, SAPFs, Restricted Areas, and DoD Collateral Open Storage facilities. With a large existing portfolio...SeniorFull timeContract workPart timeWork at officeLocal areaRemote work- ...& Transfusion Medicine SME. This position is onsite... ...JOB FUNCTIONS: Serve as senior SME in blood/blood products... .../nonclinical programs, regulatory strategies, CMC, testing... ...development. FDA biologics/drug/device experience. CMC experience. DoD acquisition lifecycle experience...Full timeH1bRemote work
- ...can't sponsor H1B. Arcetyp LLC is looking for a Senior Dod Medical Product Program Manager - Clinical & Regulatory. This position is onsite and located in Fort... ...Clinical protocol/project management. Regulatory affairs and technical documentation. DoD medical acquisition...SeniorFull timeH1bRemote work
- ...experienced Systems Engineer Subject Matter Expert (SME) to support USSF space operations. You will apply senior-level SE expertise across lifecycle activities,... ...and SYD 81 to enable mission success in a fast-paced DoD environment. Ideal candidates bring DoD background,...Senior
- 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
- ...an International Treaties and Agreements Subject Matter Expert (SME) to support the Headquarters United States Air Force at the Pentagon... ...'s degree, 25 years of relevant experience, including 15 in DoD, and a TS/SCI clearance. The successful candidate will serve as the...SeniorFull timeContract work
- ...seeking a Blood Products & Transfusion Medicine SME for an onsite role in Fort Detrick, MD. You will serve as a senior SME in blood products, transfusion medicine,... ...advising on advanced medical product development and regulatory strategies. The position requires subject-...SeniorFull time
$148.3k - $266.9k
...Description:Parsons is seeking a Senior Technical Operations Advisor... ...). This position will support DoD cyber workforce and readiness... ...with established statutory and regulatory guidance.Apply knowledge of... ...operational technology networks, devices, and information.Provide...SeniorFull timeWork at officeFlexible 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$159.6k
...solutions for the medical device and diagnostics industry... ..., offering expertise in regulatory strategy, clinical trial... ...MedTech. OverviewThe VP/Senior Director, Regulatory Affairs - Neurology MedTech will... ...of medical devices, drugs and/or biologics, developing regulatory deliverables...SeniorFull timePart timeWork experience placementImmediate startWorldwide- Overview Amyx is seeking a Sr. Information Assurance/Security SME for our DOD client in the greater National Capitol Region. Responsibilities comprehensive multi-disciplinary leadership and IA related support for DoD. Must have the ability to communicate accurate...SeniorFull timeFor contractorsFlexible hours
$103.8k - $218.1k
Job Title: Senior Network Modernization & Policy Analyst Job Category: Information Technology... ...to support the Department of Defense (DoD) Chief Information Officer (CIO). This... ...Action Officer and serves as the primary SME driving enterprise-wide network modernization...SeniorFull timeContract workWork experience placementWork at officeLocal areaFlexible hours$130k - $190k
...Clearance RequiredSecretJob DescriptionPrescient Edge is seeking a Senior Mechanical Engineer to support a federal government client.... ...manufacture, and test tools, engines, machines, and other mechanical devices. They work on power-producing machines such as electric...Senior- ...DescriptionProSidian Seeks a Senior Decentralized Clinical Care SME | Healthcare and Life... ...consequences of chemical, biological, radiological, and... ...development, manufacture, and regulatory approval/ licensure/ clearance... ...and other medical devices/infrastructure vaccines and...SeniorFull timeContract workTemporary workFor contractorsWork at officeFlexible hours
- ...equipment; may troubleshoot and correct malfunctions.Following specific layout and specific diagrams to construct and package simple devices and subunits of equipment.Conducting various tests or experiments which may require minor modifications in test setups or...SeniorContract work
- ...for more information.Job DescriptionProSidian Seeks a Senior Budget Analyst - Business Transformation (BT)... ...investigations of products under its jurisdiction, such as drugs, biological products, and medical devices.The ProSidian Engagement Team Members work to Business...SeniorWork at officeRemote work
$135k - $195k
...Job Title: Cybersecurity Subject Matter Expert (SME) Clearance Required: Active DoD SECRET Work Location: Hybrid - (Washington, DC and Alexandria... ...: U.S. citizenship required Alpha Omega is seeking a senior Cybersecurity SME to support one of our federal clients....Contract workWork experience placementRemote workMonday to FridayFlexible hours- DescriptionSAIC is seeking a Senior International Agreements Manager who will be instrumental... ...advancing the Department of Defense's (DoD) strategic objectives by facilitating... ...and ensure compliance with DoD policies.Regulatory and Compliance Oversight:Oversee the legal...SeniorWork at office
$232k - $348k
Job DescriptionThe Regulatory Strategy Senior Director is a regulatory leader with... ...of global Regulatory Affairs strategies and tactics, procedures... ...requirements related to drug development, registration,... ...Experience:Bachelor's degree in Biology, Chemistry, or other...SeniorFull timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week
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