Senior CDx Regulatory Strategy Lead
Precision For Medicine
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 diagnostic clients to enable regulatory approvals and lifecycle management. The role emphasizes leadership across cross-functional teams, development of submission roadmaps, and engagement with regulatory authorities. #J-18808-Ljbffr Precision For Medicine
- CICONIX, LLC, located in Fort Detrick, MD, is seeking a Senior Regulatory Affairs Scientist to support the Defense Health Agency and ensure... ...a RAC certification and have experience with regulatory strategy for medical products. This full-time position requires a thorough...SeniorRegulatoryFull time
- ...over 70 years of excellence, seeks an adaptable Superintendent to lead on-site operations in a team-oriented environment. You will... ...Project Managers, supervise field activities, ensure safety and regulatory compliance, and build strong relationships with customers and referrals...SeniorRegulatoryFor contractors
$162k - $243k
Position Summary The Director, CDx Regulatory Consultant will be responsible for applying deep... ...expertise in companion diagnostic regulatory strategy, IVD development, quality system... ...trial design, and commercial objectives. Lead consulting engagements with pharmaceutical...RegulatoryContract work- CICONIX, LLC is seeking a Senior Technical Product Manager based in Fort... ...time role requires expertise in leading product technical operations, managing regulatory compliance, and providing... ...Responsibilities include overseeing product strategies and collaboration with cross-...SeniorRegulatoryFull time
- ...oversee multiple laboratory operations in Frederick, Maryland. This senior role demands expertise in Companion Diagnostics, particularly in Cell and Gene Therapy, and involves leadership, regulatory compliance, and operational excellence. The ideal candidate will have...Regulatory
$83.2k - $124.8k
...Job Summary The Senior Clinical Business Analyst plays a critical... ...UAT), system validations, and regulatory compliance documentation.... ...Responsibilities UAT Leadership & Execution Lead and coordinate User... ...lab technologies Develop UAT strategies, test plans, scripts, and...SeniorRegulatoryLocal area- Senior Regulatory Affairs Scientist About CICONIX CICONIX LLC is a Veteran Owned Small Business... ...a subject matter expert for regulatory strategy including identifying and mitigating risk... ...through routine reports. Lead the development of a written regulatory...SeniorRegulatoryFull timeContract workWork at officeNight shiftWeekend work
- Banner Life Insurance Company is seeking a senior leader to head the Policy & Premium Services organization... ..., and customer satisfaction. You will lead strategy with the operations leadership team and ensure regulatory compliance and strong vendor relationships. Responsibilities...Regulatory
- ...Diagnostics / Site Head to oversee laboratory operations in Frederick, Maryland. This senior leadership role will ensure scientific excellence and operational efficiency while managing CDx programs from development to commercialization. The ideal candidate will possess a...Senior
- ...ASI is seeking a seasoned, mission-driven Senior Underwriter to join our specialized team... ..., developing sound coverage and pricing strategies, and ensuring the long-term financial... ...areas, prior claims history, licensure and regulatory standing, jurisdictional exposure, and...SeniorRegulatoryFull timeWork at office
$108k - $130k
Lead Proposal Analyst - Curtiss-Wright Nuclear Division The Curtiss-Wright Nuclear Division... ...to develop winning proposal strategies. Obtain bids from outside suppliers and... ...submitted. Ensure adherence to solicitation and regulatory requirements, including timely...RegulatoryFor contractorsWork at office$108k - $130k
Lead Proposal Analyst Our Curtiss-Wright Nuclear Division team... ...sales, finance, contracts, and senior management to create... ...developing winning proposal strategies Obtaining bids from outside... ...adherence to solicitation and regulatory requirements, including timely...RegulatoryFor contractorsWork experience placementWork at office- ...ensuring safety, quality, and contract compliance. Responsibilities include directing subcontractors, budgeting, progress payments, and design reviews while maintaining regulatory compliance and strong client communication. Travel up to 20% may be required. #J-18808-Ljbffr...SeniorRegulatoryContract workFor subcontractor
- ...analytical methods and oversee sample testing. The role involves ensuring compliance with cGMP standards and preparing documentation for regulatory agencies. The ideal candidate possesses a PhD and extensive experience in flow cytometry and cell culture methodologies. The...SeniorRegulatory
- ...severe autoimmune diseases. Our lead asset, Descartes‑08, an anti‑... ...rigorous clinical science, regulatory excellence, and rapid... ...strategically minded Director or Senior Director of Biostatistics to... ...and help shape the analytical strategy for our emerging in‑vivo CAR‑...SeniorRegulatoryContract workInterim role
- General Dynamics Information Technology in Frederick, Maryland seeks a Senior Human Subjects Protection Scientist to support the Office of Research and Regulatory Compliance (ORRC), OHRO, at DHA R&D. You will review protocols for compliance with Federal, DoD, FDA, and Army...SeniorRegulatoryWork at office
- ...Senior Technical Product Manager About CICONIX: CICONIX LLC is a Veteran Owned... ...the Product Technical Operations lead at the individual team level by providing regulatory and technical support to the development of manufacturing strategies and execution of investigational...SeniorRegulatoryFull timeContract workWork at officeNight shiftWeekend work
$110k - $135k
...disparate systems and devices. Summary The Senior Brain Health Analyst (SME) provides... ...Support Support brain health research strategy: Provide expert support to the development... ...Advise on the adherence to all necessary regulatory, ethical, and compliance requirements (e...SeniorRegulatoryContract workFor contractors$150k - $185k
...This role requires substantial experience in quality systems within biomedical or regulatory environments. The successful candidate will have strong auditing skills, the ability to lead teams, and will be responsible for developing quality control processes and conducting...SeniorRegulatory- Bunzl Distribution NA in Colorado is seeking a Sourcing Manager to lead sourcing initiatives, manage supplier relationships, and drive... ...quoting and product management activities, develop category strategies, and coach a high-performing sourcing team. #J-18808-Ljbffr Bunzl...
- ...and maintenance of calibration records. Responsibilities include coordinating calibration activities, generating calibration reports, and ensuring adherence to quality systems and regulatory standards. #J-18808-Ljbffr Frederick National Laboratory for Cancer ResearchSeniorRegulatory
- ...Frederick, Maryland. The role involves developing new business opportunities, managing client portfolios, and ensuring compliance with regulatory guidelines. Ideal candidates will have extensive experience in banking, excellent interpersonal skills, and the ability to...SeniorRegulatory
- Piper Companies is seeking a Senior Policy Manager to enhance its insurance operations in Maryland. This hybrid role involves leading the Policy and Premium Services department while ensuring compliance with rigorous standards. The ideal candidate has over 6 years of leadership...Senior
- ...and supporting technology transfer to manufacturing. The ideal candidate will have 6+ years of relevant experience, knowledge of regulatory expectations, and a degree in a science-related field (Master's preferred). Comprehensive benefits are included in the compensation...SeniorRegulatory
- ...Research is seeking a Quality Assurance Specialist IV to provide senior oversight of Good Clinical Laboratory Practice (GCLP)... ...role ensures rigorous scientific standards, data integrity, and regulatory compliance across clinical research and vaccine studies. Candidates...SeniorRegulatoryFull time
- ...biology and tissue repair. Our lead therapeutics are in the... ...projects. Position Summary The Senior Director of Quality is an senior... ..., partnering closely with Regulatory Affairs, R&D, Manufacturing,... ...10(k), or De Novo submission strategies — specifically quality module...SeniorRegulatory
- ...extensive experience in facility management or contract management. The role includes setting expectations with clients and ensuring quality control, as well as meeting safety standards according to regulatory requirements. #J-18808-Ljbffr Valiant Integrated ServicesSeniorRegulatoryContract work
- ...programs, ensuring compliance with FAA regulations, and maintaining quality management systems. You will be the primary contact for regulatory bodies and will oversee corrective actions, conduct audits, and provide training on quality processes. This position offers an...Regulatory
- CICONIX is seeking a full-time Regulatory Risk & Quality Manager at Fort Detrick, MD. This role supports the Office of Regulated Activities... .... Responsibilities include managing knowledge systems, leading audits, and maintaining training compliance. Candidates must be...RegulatoryFull timeWork at office
- Facility Services, Inc. (FSI) seeks a Water Treatment Plant Manager to oversee the operation, maintenance, and regulatory compliance of the USAMRIID Wastewater Treatment Plant, supporting a premier Department of Defense research facility. The role combines hands-on leadership...Regulatory
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