Head of Companion Diagnostics & Regulatory Strategy
Precision Medicine Group
Precision Medicine Group in Frederick, MD seeks a Senior Director, Companion Diagnostics to oversee laboratory activities supporting both commercial CDx analyses and development programs. The role requires deep knowledge of FDA guidance and experience translating it into robust, pass-ready assays. You will lead design, validation, and CLSI/CLIA/CAP compliant operations, mentor staff, monitor KPIs, coordinate audits, and collaborate with QA, Regulatory and project teams to ensure timely client #J-18808-Ljbffr Precision Medicine Group
- 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... ...sponsor responsibilities compliance, developing regulatory strategies, and supporting submissions to CDER, CBER, and CDRH....RegulatoryWork at office
- Goldbelt Apex seeks a Regulatory Affairs Support - WEMT to guide regulatory strategies across drugs, biologics, blood products and medical devices, ensuring compliance throughout the product lifecycle. You will prepare and review INDs, NDAs, PMAs, 510(k)s, technical files...Regulatory
- 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 FDA and regulatory...Regulatory
$150k - $185k
Director of Laboratory Quality and Regulatory Compliance Lead our laboratory quality and... ...firm that helps healthcare providers and diagnostic laboratories build, launch, and operate... ...Officer, with real influence over strategy, service design, staffing, and growth....RegulatoryFull timeLocal area$16.06 - $18.36 per hour
...Patient Care Companion - Full time - Day Shift Job Category : Patient Care-Non RN Requisition Number : PATIE012576 Posted : September... ...Frederick Health Compliance Program, including following all regulatory requirements and the Frederick Health Standards of Behavior. Essential...RegulatoryHourly payFull timeTemporary workPart timeImmediate startShift workDay shift- Precision Medicine Group, LLC. is seeking a Senior Director, Companion Diagnostics to oversee lab activities in Frederick, MD. The role... ...manage cross-functional projects, and collaborate with QA/Regulatory to ensure delivery and client satisfaction. #J-18808-Ljbffr...Regulatory
$203.2k - $304.8k
...Position Summary: The Senior Director, Companion Diagnostics (sitting onsite in Frederick, MD) will be responsible for overseeing the laboratory... ...will train and mentor staff to ensure scientific rigor and regulatory compliance to GxP, CLSI, CLIA/CAP and State DOH (eg.,NY, CA...RegulatoryFull timeLocal 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
- ...SME across blood products, blood operations, and transfusion medicine, guiding product managers in advanced development and regulatory strategies. You will support clinical and regulatory programs, review documentation, and participate on IPTs, communicating risks and recommendations...Regulatory
- ...medicine, and related operations. You will advise product managers on advanced medical product development and participate in regulatory strategies and testing. This role includes reviewing technical documentation, collaborating on IPTs, and traveling up to 30% to support...Regulatory
- ...Management Support Specialist to support a government customer in Frederick, MD, focusing on Force Health Protection program management, regulatory compliance, and clinical trial coordination. You will train staff on GCP, IND processes, and FDA regulations, and interact with...Regulatory
- ...oversight for FDA-regulated clinical studies, ensuring studies are executed in accordance with approved protocols, budgets, timelines, regulatory requirements, and quality standards.Duties and ResponsibilitiesManage all phases of clinical trial startup, conduct, and closeout...Regulatory
$58.8k - $77.44k
...protocol worksheets, adverse event reports, institutional review board documents, and annual continuing review reports.Maintains regulatory documents in accordance with USOR SOP and applicable regulations. May participate in scheduling monitoring and auditing visits, as...RegulatoryFull timeWork experience placementWork at officeMonday to Friday- ...Trial Manager to provide leadership and operational oversight for FDA-regulated studies, ensuring protocols, budgets, timelines, regulatory requirements, and quality standards are met. The role focuses on startup, conduct, and closeout phases, coordination with sites,...Regulatory
- ...support a government client at Fort Detrick, Frederick, MD. The role covers medical devices, diagnostics, drugs and biologics, with expertise in clinical trial planning and regulatory compliance. Responsibilities include developing clinical protocols, coordinating trial...Regulatory
- Bering-Alaka`ina Holdings, LLC is seeking a Regulatory Affairs Support Subject Matter Expert to provide regulatory guidance for government... .... The role supports preparation of submissions and regulatory strategy within a multi-disciplinary team. The ideal candidate has 6-8...Regulatory
- ...requires expertise in leading product technical operations, managing regulatory compliance, and providing support for investigational products... ...requirements. Responsibilities include overseeing product strategies and collaboration with cross-functional teams to enhance...RegulatoryFull time
- Goldbelt Apex is seeking a Regulatory Affairs Support to develop and review regulatory strategies for drugs, biologics, blood products, and medical devices. The role involves preparing INDs/NDAs/PMAs/510(k)s, technical files, and clinical evaluation reports while supporting...Regulatory
- ...Associate Director, the specialist helps implement quality and CI strategies across multiple operational areas, supports root cause... ...investigations, drives process improvements, and ensures compliance with regulatory and internal standards. This position fosters a culture of...RegulatoryFull timeTemporary work
- Goldbelt Apex is seeking a Regulatory Affairs Subject Matter Expert (WPAC) to lead regulatory strategy for military-relevant drugs, biologics, blood products and medical devices. You will develop submission plans and oversee INDs, NDAs, PMAs and 510(k)s, while coordinating...Regulatory
- Bering-Alaka`ina Holdings, LLC is seeking a Regulatory Affairs Support Subject Matter Expert to provide regulatory guidance for government... ...activities. Responsibilities include preparing regulatory strategies, interacting with regulatory agencies, and mentoring team members...Regulatory
- Knowesis is seeking a Regulatory Affairs Subject Matter Expert I to provide specialized regulatory guidance for FDA processes across drugs... ...and maintain a DoD-tier clearance and deliver regulatory strategies, submissions, and lifecycle management. You will develop regulatory...Regulatory
- Goldbelt Apex, LLC, part of the Healthcare Technology Transformation Group, is seeking a Regulatory Affairs Subject Matter Expert for WPAC to lead regulatory strategies for military-relevant drugs, biologics, blood products and medical devices. Responsibilities include...Regulatory
$95k - $125k
...FT Exempt Required Degree 4 Year Degree Description Position : Regulatory Affairs Subject Matter Expert I Work Environment: Hybrid /... ...military-relevant medical solutions. Develop and review regulatory strategies, submission planning, dossier preparation, and communication...RegulatoryFull timeWork experience placementRemote work- Bering-Alaka`ina Holdings, LLC is seeking a Regulatory Affairs Support Specialist to provide regulatory guidance and support for our government... ...in Frederick, MD at Fort Detrick. The role covers regulatory strategies, submissions, and interactions with regulatory agencies to...Regulatory
- Bering-Alaka`ina Holdings, LLC is seeking a Regulatory Affairs Support Specialist to support our government customer at Fort Detrick, MD. The role focuses on regulatory strategies, submissions planning, and ensuring compliance across medical devices, drugs, and biologics...Regulatory
- Knowesis is seeking a Regulatory Affairs Subject Matter Expert I to provide specialized regulatory guidance to ensure successful product... ...health system. The role requires developing regulatory strategies, preparing submissions (INDs/NDAs/PMAs/510(k)s), and mentoring...Regulatory
- Odyssey Systems Consulting Group, Ltd. seeks a Regulatory Affairs Support SME to assist the Defense Health Agency at Ft. Detrick, MD. The... ...medicine. Responsibilities include shaping regulatory strategies, preparing submissions (INDs/NDAs/PMAs/510(k)s), and mentoring...Regulatory
- ...expertise in the areas of medical devices, diagnostics, drugs and biologics, and/or other... ...aid in the development of the research strategy for clinical trials. Provide subject matter... ...meetings. Orchestrate the requisite regulatory strategy as well as organization and...RegulatoryContract workLocal areaWork visa
$96k - $110k
...Help identify systemic issues within the unit and help develop strategies to address them to accomplish the work of the unit. Provide... ...grant reporting and writing, and ensuring that administrative and regulatory requirements are met. Fill in for the chief and assume their...RegulatoryFull timeWork at officeLocal areaImmediate start
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