Regulatory Systems Lead - FDA‑Regulated IT
US-Defense-Health-Agency
US-Defense-Health-Agency MRDC division seeks a Regulatory Systems Manager to oversee FDA-compliant IT systems in medical research and development. The role requires a degree in a health-related field and proven experience leading technical teams in regulated environments. You will draft and enforce policies, ensure eCTD documentation standards, and coordinate training and performance metrics across the organization. #J-18808-Ljbffr US-Defense-Health-Agency
- ...Developer to serve as the technical lead for the design, development,... ...trial databases supporting FDA-regulated medical product development... ...clinical databases meet FDA regulatory requirements, ICH guidelines,... ...Acceptance Testing (UAT) and system validation activities....Regulatory
- ...coding activities for adverse events, medical histories, procedures, and concomitant medications for FDA-regulated clinical trials, ensuring consistency, accuracy, and regulatory compliance. Requirements: Duties and Responsibilities Code adverse events using MedDRA...Regulatory
$38 - $43 per hour
...and mission-critical IT infrastructure.... ...all infrastructure systems and operations at the... ...continuous operations. • Lead troubleshooting... ...expert during regulatory inspections and internal... ...in a GMP-regulated biotechnology, pharmaceutical... ...• Must comply with FDA, EH&S, cGMP, and...RegulatoryHourly payPermanent employmentFull timeContract workFor contractorsMonday to FridayShift workAfternoon shift- ...infrastructure cybersecurity, system development, help desk... ...compliance with all applicable regulations, client requirements and policies... ...inspections performed by clients, regulatory agencies and outside auditors... ...an interim secret clearance leading to a top-secret clearance and...RegulatoryContract workInterim roleLocal area
- Precision for Medicine seeks a Director-level CDx Regulatory Consultant to guide global regulatory strategies for companion diagnostics and clinical trial assays. You will translate FDA, EU IVDR, and other requirements into practical plans, working with pharmaceutical and...Regulatory
- ...lives of our neighbors. As our new Agency Lead, you will be the heartbeat of our office... ...standards and state-level compliance regulations. Requirements Active Maryland Property &... ...Maryland insurance landscape and local regulatory requirements. Strong leadership background...RegulatoryWork at officeLocal areaFlexible hours
$17 - $20 per hour
...in the absence of store management, including all required systems start-ups, required cash handling, and ensuring the floor... ...products. Ensures any additional pricing tasks related to local regulations and/or regulatory compliance programs are completed accurately and within...RegulatoryHourly payWork experience placementSeasonal workLocal areaShift work- ...ensuring optimal healthcare readiness. The LNO Systems Analyst will serve as a subject matter... ...Combat Support System-Army (GCSS-A), Lead Materiel Integrator Decision Support... ...Understand and follow current medical regulations, emerging medical initiatives, and materiel...Local area
$23.04 - $30 per hour
...our manufacturing team as a Lead Operator at Thermo Fisher Scientific... ...of cGMP, ISO standards and regulatory requirements • Expert... ...with manufacturing software systems, ERP platforms, and Microsoft... ...documentation and batch record review in regulated environments • Demonstrated...RegulatoryRemote jobHourly payFull timeTemporary workWork at officeShift workAfternoon shift$22 per hour
...The Business Systems Intern will assist in solving business problems through interaction... ...to market that executives, boards, and regulators depend on. The work you do here helps organizations... ...adherence to company policies and regulatory standards. Workiva supports employees...RegulatoryRemote jobSummer workInternshipWork at office- ...bioterrorism. RESPONSIBILITIES Leads preventive maintenance,... ...in our electronic management systems. Assists senior technicians... ...corrective actions to support regulatory compliance and reliable system... ...thorough knowledge of OSHA safety regulations. OSHA 10 or 30 certification...RegulatoryInterim roleWork at office
$26.46 - $37.8 per hour
...adhering to the FH Compliance Program and all regulatory requirements and the FH Standards of... ...APR‑DRG within the hospital information system. May also code other work types as... ...of medical record practices, standards, regulations, Joint Commission on Accreditation of Health...RegulatoryHourly payFull timeTemporary workPart timeMonday to FridayFlexible hoursShift work- ...Manager to support the Office of Regulated Activities (ORA) in support of... ...the Product Technical Operations lead at the individual team level by providing regulatory and technical support to the development... ...the product accountability system up to date including but not...RegulatoryFull timeContract workWork at officeNight shiftWeekend work
$40 per hour
...Basic experience with source control systems such as Git Preferred Qualifications... ...to market that executives, boards, and regulators depend on. The work you do here helps organizations... ...adherence to company policies and regulatory standards. Workiva supports employees...RegulatoryRemote jobFull timeSummer workInternshipSummer internshipWork at office- ...accomplished by subordinates, set and adjust short-term priorities, and prepare schedules for completion of work. Ensure proper accountability of all sensitive items, weapons and equipment. Develop training plans based on approved training courses and regulatory requirements....RegulatoryTemporary workShift work
$24.27 - $33.99 per hour
Lead Certified Sterile Processing Tech - Full Time Job Category : Patient Care-Non RN Requisition Number : LEADS012313 Posted : July... ...adheres to the FH Compliance Program, including following all regulatory requirements and the FH Standards of Behavior. Under the direction...RegulatoryHourly payFull timeTemporary workPart timeShift work$22.05 per hour
...procedures, safety practices, and regulatory standards. The technician... ...while maintaining GMP, ISO, and FDA compliance.... ...required to perform as a work-order lead, coordinating tasks and supporting... ...Experience working in GMP, ISO, or FDA-regulated environments. Experience...RegulatoryContract workTemporary workMonday to FridayShift workNight shift- ...about general building maintenance and regulatory requirements within a healthcare setting... ...safety, fire, and healthcare regulations Collaborate with facility leadership... ...general repairs, plumbing, electrical systems, HVAC, and preventative maintenance...RegulatoryFor contractors
- ...Senior Technical Product 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...RegulatoryFull time
- ...support clinical trials, statistical analyses, safety reporting, and FDA submissions. Requirements: Duties and Responsibilities... ...submissions. Strong knowledge of validation practices and regulatory requirements Venesco, LLC, is an equal opportunity and...RegulatoryInterim role
$44.72k - $59.8k
...have an opportunity to contribute to the company's success. As a Lead Teller within PNC's Retail Banking organization, you will be... ...Licensing Act of 2008 (SAFE Act) and/or the Financial Industry Regulatory Authority (FINRA), which prohibit the hiring of individuals with...RegulatoryFull timeTemporary workPart time- ...Frederick, MD is seeking a Board Certified Behavior Analyst (BCBA) to lead and oversee individualized ABA treatment plans for children.... ...adjust goals as needed, and ensure compliance with ethical and regulatory standards while advancing your leadership and clinical skills....RegulatoryFull time
- ...seeking an experienced RN Supervisor to join our Maryland team. You will oversee nursing staff, coordinate resident care, and ensure regulatory compliance in a collaborative setting. This full-time role offers a supportive environment, competitive compensation, and growth...RegulatoryDaily paidFull timeRelocation package
- ...filling processes consistently meet production, quality, and regulatory objectives while supporting the successful startup of new... ...cartridge filling experience is required. Strong understanding of FDA cGMP regulations, EU GMP, Annex 1, and aseptic manufacturing principles....Regulatory
- ...in compliance with protocols, Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and sponsor requirements. Duties and Responsibilities... ...protocol compliance and identify deviations. Review regulatory binders and essential documents. Generate clinical...Regulatory
$80k - $90k
...Molecular Virology Lead TechnicianOverview: Please note that this position... ...aspect. As experts in healthcare IT experts, Apex is committed to building systems for healthcare organizations to... ...in accordance with applicable regulations and procedures.Performs a variety...Contract work- Oshkosh Corporation seeks a Hydraulic Systems Engineer to lead hydraulic cylinder resourcing, redesign, validation, and production release for mobile equipment and hydraulic systems. The role requires managing cylinder projects from scope through design approval, testing...
$75k - $80k
...Lead Registered Dietitian for the Baltimore, Fredericks and Surrounding AreasJoin Healthcare... ...with federal, state, and local regulations and guidelines.Monitor and document residents... ..., families, and staff.Knowledge of regulatory requirements and best practices in dietary...RegulatoryLocal area- Jhpiego is seeking a Laboratory Technical Advisor to lead efforts strengthening Liberia's laboratory systems, including specimen transport and LQMS. The role partners with MOH, NRL, NPHIL, and counties to improve quality, diagnostics, and referral networks. Strong leadership...
- ...is comprised of the industry's leading scientists, medical and... ...and contact us. Title: Sr. Regulatory Affairs Scientist Location:... ...shall ensure compliance with FDA Sponsor responsibilities, serve... ...assistance for Quality Management System assessments done at the manufacturing...RegulatoryFor contractors2 days per week
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