Senior Director, Companion Diagnostics: Regulatory Lead
Precision Medicine Group, LLC.
Precision Medicine Group, LLC. is seeking a Senior Director, Companion Diagnostics to oversee lab activities in Frederick, MD. The role focuses on cell therapy assay design, development and validation to support both commercial CDx and developmental programs, with strong emphasis on FDA guidance, ISO 13485, and CLSI/CAP/CLIA compliance. The ideal candidate will mentor staff, manage cross-functional projects, and collaborate with QA/Regulatory to ensure delivery and client satisfaction. #J-18808-Ljbffr Precision Medicine Group, LLC.
- ...Group in Frederick, MD, is seeking a Senior Director, Companion Diagnostics, to oversee laboratory activities... ...requires deep FDA guidance knowledge, leading design, development and validation... ...candidate will mentor staff, drive regulatory alignment with QA and Regulatory,...SeniorRegulatory
$203.2k - $304.8k
The Senior Director, Companion Diagnostics ( sitting onsite in Frederick, MD ) will be responsible for overseeing... ...use their scientific expertise to lead design, development and validation... ...to ensure scientific rigor and regulatory compliance to GxP, CLSI, CLIA/CAP and...SeniorRegulatoryLocal area- CICONIX, LLC is seeking a 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...SeniorRegulatoryFull time
- ...Senior Technical Product Manager About CICONIX: CICONIX LLC is a Veteran Owned Small Business specializing in... ...Role: Function as the Product Technical Operations lead at the individual team level by providing regulatory and technical support to the development of manufacturing...SeniorRegulatoryFull timeContract workWork at officeNight shiftWeekend work
- Job Openings Senior Manager OR Associate Director, Accounting & SEC Reporting (2731125) About the job Senior... ...cycle and supports the preparation of regulatory filings, ensuring accurate and... ...control frameworks. Key Responsibilities: Lead an efficient monthly close process...SeniorRegulatory
$68k - $80k
...directly to the production of Next Generation Sequencing (NGS) diagnostic kits and Molecular Diagnostics products within a GMP‐compliant... .... You ensure that manufacturing activities meet applicable regulatory requirements while driving process robustness, operational excellence...SeniorRegulatoryWork at officeLocal area$17.51 - $18.36 per hour
...Patient Care Companion - Full Time - Day Shift Job Category: Patient Care-Non RN Hourly Range: $17.51 - $18.36 Job Summary:... ...Frederick Health Compliance Program, including following all regulatory requirements and the Frederick Health Standards of Behavior....RegulatoryHourly payFull timeTemporary workPart timeImmediate startShift workDay shift- CICONIX, LLC, located in Fort Detrick, MD, is seeking a Senior Regulatory Affairs Scientist to support the Defense Health Agency and ensure compliance with FDA regulations. The ideal candidate will possess a RAC certification and have experience with regulatory strategy...SeniorRegulatoryFull time
$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$80k - $90k
...SOPs, and ensures high-quality diagnostic and research testing using... .... Ensure compliance with regulatory standards (CLIA, CAP, etc.).... ...goals, participates in or leading development of research work... ...management, in coordination with director, Investigators, or other...Regulatory- A leading cancer research facility located in Maryland is seeking a Scientist-2 to direct the Pharmacokinetics & Biopharmaceutics Research Laboratory. The role focuses on developing R&D programs and bioanalytical methods to support drug discovery and clinical trials. The...
- ...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
- Leonardo DRS is looking for a Senior Principal Systems Engineer in Frederick, MD, who will analyze and design advanced systems. This role includes responsibilities like mentoring engineers, ensuring project success, and engaging in business development. At Leonardo DRS...SeniorFlexible hours
- 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
- ...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
- ...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
- ...particularly FAA requirements. Serve as the primary point of contact for all quality-related communications with the FAA and other regulatory bodies. Oversee corrective action processes and ensure timely resolution of discrepancies and non-conformances. Develop,...Regulatory
- ...Senior Business Analyst Frederick, MD, USA The Senior Clinical Business Analyst plays... ...Testing (UAT), system validations, and regulatory compliance documentation. This position serves... ...include but are not limited to: Lead and coordinate User Acceptance Testing (...SeniorRegulatory
- ...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
- ...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
- Banner Life Insurance Company in Frederick, MD is seeking a Senior Manager of Policy & Premium Services to provide strategic leadership... ...achieving customer satisfaction and ensuring compliance with regulatory requirements. The ideal candidate will have 6+ years in leadership...SeniorRegulatory
- Theradaptive, Inc. is looking for a Senior Director of Quality to lead and enhance the company's Quality Management System (QMS). This role will ensure... ...and medical devices, requiring significant expertise in regulatory affairs and quality systems. The ideal candidate has...SeniorRegulatory
- Precision Medicine Group, LLC. in Frederick, MD seeks a Senior Clinical Business Analyst to support laboratory technology initiatives with a strong emphasis on UAT, system validations, and regulatory documentation. The role requires coordinating cross‑functional teams across...SeniorRegulatory
- ...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
$100k - $130k
Corporates Ratings - Associate Director (MD) Frederick, Maryland... ...challenging work with exposure to senior staff and external market... ...participants. Job Responsibilities: Lead the rating process by... ...interest to KBRA. * KBRA maintains regulatory requirements and expects...RegulatoryFull timeContract workTemporary workFor contractorsFor subcontractorWork at officeLocal areaVisa sponsorship- MDAEdge is hiring a Business Development Manager located in Frederick, Maryland, who will be responsible for building corporate market position and developing Federal business opportunities. The ideal candidate will have at least five years of experience in business development...Senior
$140k - $165k
Piper Companies is looking for a Senior Policy Manager to join a thriving insurance company... ...Duties of the Senior Policy Manager : Lead the Policy and Premium Services department... ...100% compliance with all state and other regulatory entities Innovate and lead improvements...SeniorRegulatoryTemporary work3 days per week- CICONIX is seeking a Senior Human Subjects Protection Scientist to support the IRB at the Office of Human Research Oversight (OHRO) under MRDC at Ft. Detrick, Maryland. The role involves pre-review of protocols, lifecycle management post-IRB approval, and participation...SeniorWork at office
- BCI Acrylic Inc. is looking for a motivated Project Manager to lead installation projects from concept to completion. You will ensure each project meets our high standards of quality and customer satisfaction. Your role includes guiding the team, communicating with clients...Senior
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