Regulatory Affairs SME - Drugs, Biologics & Devices
Kapili Services, LLC
Bering-Alaka`ina Holdings, LLC is seeking a Regulatory Affairs Support Subject Matter Expert to provide regulatory guidance for government-facing medical solutions at Fort Detrick, Frederick, MD. The role supports preparation of submissions and regulatory strategy within a multi-disciplinary team. The ideal candidate has 6–8 years of regulatory experience in drugs, biologics, or devices, with strong knowledge of FDA regulations and lifecycle management and the ability to work independently and #J-18808-Ljbffr Kapili Services, LLC
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Regulatory Affairs SME - Drugs, Biologics & Devices in Frederick, MD vacancy
- 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...Suggested
$100k - $150k
...data across different systems and devices. Summary: Goldbelt APEX is looking for aRegulatory Affairs Subject Matter Experts - WPAC. Responsibilities... ...Job Functions: Serve as senior regulatory SME supporting military-relevant drugs, biologics, blood products, medical devices...SuggestedContract work- Knowesis is seeking a Regulatory Affairs Subject Matter Expert I to provide specialized regulatory guidance to ensure successful... ...initiatives. This expert navigates complex FDA processes for drugs, biologics, and devices to bring acute care capabilities to the military health...Suggested
$65k - $110k
...Summary Odyssey is looking for a Regulatory Affairs Support (Warfighter Expeditionary... .... This Regulatory Affairs Support SME provides specialized guidance and... ...submission, and lifecycle management for drugs, biologics, and medical devices utilized in expeditionary medicine...SuggestedFull timeContract workTemporary workWork experience placementLive outRemote workFlexible hours$95k - $125k
...Exempt Required Degree 4 Year Degree Description Position : Regulatory Affairs Subject Matter Expert I Work Environment: Hybrid /... ...initiatives. This expert navigates complex FDA processes for drugs, biologics, and devices to bring acute care capabilities to the military health...SuggestedFull timeWork experience placementRemote work$95k - $125k
...and exchange data across different systems and devices. Summary Goldbelt APEX is looking for a Regulatory Affairs Support - WEMT. Responsibilities Essential Job... ...Develop and review regulatory strategies for drugs, biologics, blood products, and medical devices. Prepare/...Contract work$78k - $81k
Regulatory Affairs Scientist About CICONIX: CICONIX LLC is a Veteran Owned Small Business specializing... ...communications with the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health submissions....Full timeWork at officeNight shiftWeekend work- Regulatory Risk & Quality Manager Regulatory Risk & Quality Manager position at CICONIX LLC, a Veteran Owned Small Business specializing... .... Ensure regulatory compliance for all medical products (drugs, biologics, devices) per applicable guidance and regulations. Develop,...Full timeContract workFor contractorsWork at officeNight shiftWeekend work
- ...Operations lead at the individual team level by providing regulatory and technical support to the development of... ...analytical procedures, and appropriate acceptance criteria) for drug, biologic, medical devices, and combination products. Write, review, and/or revise...Full timeContract workWork at officeNight shiftWeekend work
CICONIX
Frederick, MD4 days ago - ...defending the nation against biological threats. Established in response... ...as a subject matter expert (SME) for specialty facility... ...critical systems, including field devices such as actuators, control... ...corrective actions to support regulatory compliance and reliable system...Interim roleWork at office
- ...Manager based in Fort Detrick, Maryland. This full-time role requires expertise in leading product technical operations, managing regulatory compliance, and providing support for investigational products. Ideal candidates will possess relevant educational backgrounds,...Full time
CICONIX
Frederick, MD22 hours ago - ...investigations, drives process improvements, and ensures compliance with regulatory and internal standards. This position fosters a culture of... ...and/or education level. Inotiv is a growing contemporary drug discovery and development company where we "Play to Win" in an...Full timeTemporary work
Inotiv
Frederick, MD4 days ago $43k - $44.63k
...Manufacturer Statements of Origin) and vehicle titles ~ Accurately record inventory status and audit findings using a mobile device audit application ~ Document dealership visit details and audit observations ~ Review audit results with dealership...Temporary workLive inImmediate startFlexible hoursNight shiftDataScan
Buckeystown, MD1 day ago$85k - $140k
...also may include a discretionary bonus component. Morgan Stanley offers a full spectrum of benefits, including Medical, Prescription Drug, Dental, Vision, Health Savings Account, Dependent Day Care Savings Account, Life Insurance, Disability and Other Insurance Plans,...Temporary workLocal areaHome office- ...the physical ability to pass agility components of the selection process Possess the physical and mental ability to meet medical, drug, and psychological screening requirements Possess an excellent moral character and background that will withstand a comprehensive background...Permanent employmentFull timeLocal areaLong distanceAfternoon shift
$120k - $125k
...analysis to support the customer's Pandemic Warning Mission. The SME shall possess mid-level skills and experience to exploit all... ...sciences field of study (e.g., Public Health, Epidemiology, Virology, Biology, Microbiology, Biomedical Science). 4+ years relevant...Full timeFor contractors$148.89k
...veteran status, citizenship status, genetic information or any other characteristic protected by applicable law. Background Check and Drug Testing Information CDM Smith Inc. and its divisions and subsidiaries (hereafter collectively referred to as “CDM Smith”) reserves...Work experience placementH1bWork at officeRelocationCDM Smith
Frederick, MD4 days ago$78.17k - $103.86k
...Location: Remote Department: Veterans Affairs Type: Full Time Min. Experience:... ...product functional Subject Matter Expert (SME) Lead and mentor junior analysts in accordance... ..., employment and education verification, drug testing, and creditworthiness. Syms...Full timeFor contractorsRemote workSyms Strategic Group, LLC (SSG)
Frederick, MD22 hours ago- ...biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials... ...the CLIA laboratories as part of regulatory meetingsSupport best practices for clinical... ...understanding of commonly used molecular biology techniques, oncology and clinical researchAbility...Full timePart timeWork at office
- ...technical, procedure, and policy writing KTL Solutions Systems is an equal opportunity/ affirmative action employer and an alcohol and drug free workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex,...For contractorsWork at officeRemote work
KTL Solutions Inc
Frederick, MD21 days ago $18 - $26 per hour
...04 BUCKEYSTOWN PIKE, FREDERICK, MD 21704-8312, United States of America Walmart and its subsidiaries are committed to maintaining a drug-free workplace and has a no tolerance policy regarding the use of illegal drugs and alcohol on the job. This policy applies to all employees...Hourly payMinimum wageFull timeTemporary workPart timeShift work- ...other national and international regulatory bodies. We specialize in... ...compounding pharmacy, and medical device facilities throughout the Mid... ...services on cleanrooms, biological safety cabinets (BSCs), laminar... ...~ Must be able to pass a drug and background check...Work at officeLocal areaImmediate start
- ...duties as assigned Requirements: Must complete a DOT physical and drug testing High attention to detail Self-motivated team player,... ...computer hardware and peripherals, along with other electronic devices Ability to recognize electronics and components that have value...Shift work
- ...work orders. Sets up warning signs, barriers, flags, relays hand-signals, directs traffic and other applicable traffic control devices to protect employees and members of the public from hazards in and around the work area. Cooperates with property owner, customer,...Contract workLocal area
Wright Tree Service
Frederick, MD22 hours ago - CICONIX LLC is seeking a Regulatory Affairs Scientist to support the Office of Regulated Activities for the DHA R&D MRDC team in Fort Detrick, MD. The role focuses on ensuring FDA sponsor responsibilities compliance, developing regulatory strategies, and supporting submissions...Work at office
$30 per hour
...client-facing roles may be required to comply with applicable requirements, such as immunization/occupational health mandates, and/or drug testing requirements. Range and benefit information provided in this posting are specific to the stated locations only US:...Hourly payTemporary workWork experience placementInternshipWorldwideFlexible hoursOracle
Frederick, MD1 day ago- ...to foster a safe work environment through job site inspections, regulatory compliance, and continuous improvement initiatives. Responsible... ...able to function at a high level independently and as part of a team. Must be able to pass a background check and drug test....Local areaLong distance
Digging & Rigging, Inc.
Frederick, MD22 hours ago $115k - $130k
...experience applying computational methods in biological laboratory settings is necessary, with... ...by the Secretary of Veterans Affairs; or a person who was discharged or released... ...substance use disorder (not currently using drugs illegally) Autoimmune disorder, for example...Full timeContract workFor contractorsFor subcontractorWork at officeLocal areaRelocationFlexible hours- Lonza Biologics, Inc. seeks an Associate Director of Quality Assurance to lead the site Quality Systems organization in Walkersville... ...coach a high‑performing team, interface with manufacturing, regulatory affairs and site leadership, and support audits and regulatory...
$75k - $85k
...more. Skill in managing fine motor tasks, such as helping students with writing, manipulating small objects, or using adaptive devices. Ability to operate a computer or tablet for up to 8 hours daily. Capacity to notice and respond to non-verbal cues from students...Work at officeLocal areaLittle Leaves
Frederick, MD1 day ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs SME - Drugs, Biologics & Devices. Be the first to apply!
Related searches
- regulatory scientist Frederick, MD
- regulatory law Frederick, MD
- regulatory technician Frederick, MD
- regulatory Frederick, MD
- regulatory engineer Frederick, MD
- clinical research regulatory Frederick, MD
- regulatory contract Frederick, MD
- food regulatory Frederick, MD
- compliance technician Frederick, MD
- ethics compliance Frederick, MD