Senior DoD Regulatory Affairs SME - Drugs & Devices
Arcetyp LLC
Arcetyp LLC is seeking a Senior DoD Regulatory Affairs SME to lead regulatory strategy for drugs, biologics, blood products, and medical devices, onsite at Fort Detrick, MD. You will develop submission plans, prepare INDs/NDAs/PMAs/510(k)s, and advise cross-functional teams on regulatory risks and lifecycle strategies while mentoring colleagues, with a focus on DHA/DoD program requirements. #J-18808-Ljbffr Arcetyp LLC
Vacancy posted 9 hours ago
Similar jobs that could be interesting for youBased on the Senior DoD Regulatory Affairs SME - Drugs & Devices in Frederick, MD vacancy
- ...We do 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 senior...SeniorFull timeH1b
- Bering-Alaka`ina Holdings, LLC is seeking a Regulatory Affairs Support Subject Matter Expert to provide regulatory guidance for government... ...candidate has 6-8 years of regulatory experience in drugs, biologics, or devices, with strong knowledge of FDA regulations and lifecycle...Suggested
- ...Dynamics IT seeks a seasoned Regulatory Affairs Subject Matter Expert to provide senior-level regulatory leadership... ...for Medical Products. The SME guides regulatory... ...and lifecycle management of drugs, biologics, blood products, devices, and diagnostics. #J-18808...Senior
- Arcetyp LLC is seeking a Senior DoD Regulatory Affairs Specialist - Medical Products for an onsite role in Fort Detrick, MD... ...on regulatory strategy development for drugs, biologics, blood products, and medical devices, with responsibility for IND/NDAs/PMAs/510(k)...Senior
- ...seeking a Technical Advisor Support to join a DoD-focused program. You will advise product teams on clinical and regulatory strategies, review data, and help shape FDA... ...regulatory pathways for next-gen medical devices, drugs, and biologics. You will collaborate with cross...Senior
- Systems Plus, Inc. is seeking a Regulatory Affairs Subject Matter Expert in Frederick, Maryland. This full-time, hybrid role focuses on directing regulatory strategy across drugs, biologics, medical devices and related medical solutions to support military and federal...Full time
- ...Compliance Requirements, FDA Regulatory Requirements,... ...Summary The Regulatory Affairs Subject Matter Expert (SME) provides senior-level regulatory leadership... ...lifecycle management of drugs, biologics, blood and blood products, medical devices, diagnostics, and other...For contractors
- ...sponsor H1B. Arcetyp LLC is looking for a Senior DoD Regulatory Affairs Specialist - Medical Products . This position... ...Develop and review regulatory strategies for drugs, biologics, blood products, and medical devices. Prepare/review INDs, NDAs, PMAs, 510(k)s,...SeniorFull timeH1b
- Goldbelt Apex LLC is seeking a Regulatory Affairs Support - WEMT to develop and review regulatory strategies for drugs, biologics, blood products, and medical devices. The role includes preparing regulatory submissions and supporting interactions with regulatory agencies...
- Bering-Alaka`ina Holdings, LLC is seeking a Regulatory Affairs Support Subject Matter Expert to provide regulatory guidance for government... ..., Frederick, MD. The role requires deep expertise in drug, biologic, and device regulation and the ability to manage submissions and...
- ...Blood Products & Transfusion Medicine SME to provide senior technical expertise onsite at Fort Detrick... ...supports medical product development, regulatory strategies, and testing, with travel... ..., and regulatory documentation in DoD and DoD-related projects. #J-18808-Ljbffr...Senior
- Bering-Alaka`ina Holdings, LLC in Frederick, MD seeks a Regulatory Affairs Support SME to provide expert guidance on regulatory strategies for military-relevant medical solutions across drugs, biologics, and devices. You will develop submission plans (INDs, NDAs, 510(k)s...
- Arcetyp LLC seeks a DoD Medical & Clinical Research Advisor to provide senior clinical and scientific guidance for medical devices, diagnostics, drugs, and biologics. The role focuses on clinical... ...management, protocol review, and regulatory submissions in support of DoD...Senior
- ...Position Summary The Regulatory Affairs Subject Matter Expert (SME) provides senior-level regulatory... ...lifecycle management of drugs, biologics, blood and blood products, medical devices, diagnostics, and other... ...negotiations. Familiarity with DoD acquisition frameworks...Contract workFor contractorsWork at officeWork from homeFlexible hours
- ...Consulting Group, Ltd. seeks a Regulatory Affairs Support SME to assist the Defense Health Agency... ..., and lifecycle management for drugs, biologics, and medical devices used in expeditionary medicine.... ...teammates on best practices in a DoD #J-18808-Ljbffr Odyssey Systems...
- ...Medical Logistics Command and Force Projection Directorate. This senior role maintains, calibrates, and upgrades critical medical... ...diagnostics, mentor junior technicians, and ensure compliance with DoD and FDA standards. Candidates should have extensive CMMS experience...Senior
- ...& Transfusion Medicine SME . This position is onsite... ...FUNCTIONS: Serve as senior SME in blood/blood products... .../nonclinical programs, regulatory strategies, CMC, testing... .... FDA biologics/drug/device experience. CMC experience. DoD acquisition lifecycle experience...Full timeH1b
- ...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 timeH1b
- Allied Technologies and Consulting, LLC is seeking a Regulatory Affairs SME in Maryland to provide senior regulatory leadership for medical product development and acquisition programs, including FDA and DoD-related regulatory activities. The role requires RAC certification...
- ...efforts to advance translational antiviral drug discovery. Research activities will... ...Learning the operational, scientific, and regulatory steps required to translate in vitro molecular... ...enter an employment relationship with DoD or any other agency, this opportunity will...Contract workInternshipWork at officeImmediate start
- ...Arcetyp LLC is looking for a DoD Medical & Clinical... ...Provide medical/scientific SME support for medical devices, diagnostics, drugs, biologics, blood... ...documentation, safety data, and regulatory submissions. Support FDA... ...data and provide senior-level recommendations. MINIMUM...Full timeH1b
$130k - $150k
...disposal, chemical inventories, and required regulatory reporting, coordinating with local fire... ...Pharmaceutical, biopharma, and medical device manufacturing backgrounds transfer well.... ...titles such as EHS Manager, EHS Lead, Senior EHS Specialist, EHS Engineer, HSE...Permanent employmentFull timeFor contractorsSummer workLocal areaRelocation package- Arcetyp LLC in Frederick, MD is seeking a Senior Acquisition Program Manager to lead CIVDEP support activities onsite at Fort Detrick.... ...risks and schedules, and ensuring efficient program execution for DoD and DHA programs. The position requires strong DoD acquisition...Senior
- Arcetyp LLC is actively recruiting for a Senior Program Manager overseeing DoD healthcare programs at Fort Detrick, MD. This onsite role requires coordinating large, multidisciplinary teams and managing government-facing relationships with CORs and leadership. The ideal...SeniorContract work
- ...You will influence acquisition strategies and collaborate with senior government and industry stakeholders on high-visibility programs... ...IPTs, reviewing program-management documentation, and ensuring alignment with DHA/DoD objectives. #J-18808-Ljbffr Systems Plus, Inc.Senior
- Arcetyp LLC, a growing consulting firm serving US Federal Government, is seeking a Senior DoD Medical Product Program Manager - Clinical & Regulatory. This onsite role is located at Fort Detrick, MD. The position entails leading regulatory documentation, clinical protocol...Senior
- ...Frederick, MD to provide advanced IM/IT and information assurance support for CDMRP, including RMF certification, FISMA compliance, and senior IT guidance. You will lead Tier 3 IT efforts, manage IA documentation, and coordinate security activities across systems, networks,...Senior
- A technology services company in Maryland is seeking a Senior Registered Communications Distribution Designer (RCDD) to lead the design and maintenance of cable infrastructure supporting the DoD environment. The ideal candidate will have at least 10 years of relevant experience...SeniorFull time
- BryceTech is seeking a Program Logistics Manager to provide senior-level lifecycle logistics, IPS, and fielding support for Army PM M2S... ...programs in the United States. You will work with PMs, engineers, DoD stakeholders and external partners to ensure supportability and...Senior
- Bering-Alaka`ina Holdings, LLC is seeking a Senior Product Management Support (Team Lead) to bolster our government customer at Fort Detrick, MD. The role demands deep DoD acquisition expertise and coordination across IPTs, meetings, and reviews to drive medical product...Senior
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior DoD Regulatory Affairs SME - Drugs & Devices. Be the first to apply!
Related searches
- senior devops engineer remote Frederick, MD
- senior implementation engineer Frederick, MD
- senior electronic technician Frederick, MD
- remote senior project manager Frederick, MD
- senior payroll accountant Frederick, MD
- senior manager product engineering Frederick, MD
- legal senior counsel family office Frederick, MD
- senior human factors engineer Frederick, MD
- senior property accountant Frederick, MD
- senior software engineer Frederick, MD

