Regulatory Affairs Manager
1 week ago
Candidate is expected to establish and administer quality systems supporting compliant nonclinical laboratory study GLP and or phases thereof and testing activities producing primary or secondary endpoints of clinical studies GCLP. The individual should assure that facilities, equipment, personnel, methods, practices, records, and controls are in conformance of regulations.
Main Responsibilities:- GLP Compliance: Establish company compliance of GLP and GCLP and GCPs for FDA and applicable international regulations.
- QA Standard Operating Procedures: Establish and administer QA Standard Operating Procedures (SOPs), QA Files, and QA Audit Log.
- Bachelor's degree in biological or physical sciences required; advanced degrees preferred.
- 10+ years of relevant Regulatory Affairs experience in the Bioanalytical CRO space and/or biotechnology/pharmaceutical industry.
- Able to provide regulatory leadership and guidance on cross-functional teams.
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Regulatory Affairs Director
4 weeks ago
Pleasanton, Kansas, United States AbbVie Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Director to join our team at AbbVie. As a key member of our regulatory team, you will be responsible for planning and preparing complex regulatory documents for US and ROW product approvals.About UsAbbVie is a leading global biopharmaceutical company that discovers and delivers innovative...
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Pleasanton, Kansas, United States Abbott Laboratories Full timeAbout the RoleWe are seeking a highly experienced Regulatory Affairs Specialist to join our team at Abbott Laboratories in Pleasanton, CA. As a key member of our Heart Failure Division, you will play a critical role in ensuring the regulatory compliance of our medical devices.Key ResponsibilitiesDevelop and implement global regulatory strategies for new and...
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Global Regulatory Compliance Manager
4 days ago
Pleasanton, Kansas, United States AbbVie Full timeKey ResponsibilitiesThe successful candidate for this Global Regulatory Compliance Manager role will have extensive experience in regulatory affairs, particularly in medical device manufacturing companies, and be well-versed in FDA QSR, ISO 13485, and other relevant regulations.
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Global Regulatory Lead
2 weeks ago
Pleasanton, Kansas, United States AbbVie Full timeAbout the RoleWe are looking for a highly skilled Global Regulatory Lead to join our team at AbbVie. As a key member of our regulatory affairs group, you will be responsible for developing and implementing regulatory strategies to support lifecycle management.The ideal candidate will have extensive knowledge of regulatory requirements and regulations, with...
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Regulatory Compliance Lead
1 week ago
Pleasanton, Kansas, United States Crystal Pharmatech Full timeAbout the RoleCandidates should have 10+ years relevant Regulatory Affairs experience in the Bioanalytical CRO space and/or biotechnology/pharmaceutical industry or a combination of education and experience.As a QA Operations Manager, you will support organization regulatory professionals across BABM sites and establish company compliance of GLP and GCLP and...
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Quality Assurance Director
6 days ago
Pleasanton, Kansas, United States Crystal Pharmatech Full timeJob OverviewWe are seeking a highly skilled Quality Assurance Director to join our team at Crystal Pharmatech.The successful candidate will be responsible for ensuring compliance with Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP) regulations in our nonclinical laboratory study.Main Responsibilities:Inspection Management: Host...
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RD Consulting Engagement Manager
4 weeks ago
Pleasanton, Kansas, United States Lifelancer Full timeJob Title: RD Consulting Engagement Manager - Life Sciences R&D SpecialistJob Location: United StatesJob Location Type: RemoteJob Contract Type: Full-timeJob Seniority Level: Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS...
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Senior Life Sciences Consulting Manager
1 week ago
Pleasanton, Kansas, United States Lifelancer Full timeLife Sciences Consulting RoleWe are seeking an experienced RD Strategy and Operations Expert to join our team at Veeva Systems.About the Company:Veeva is a mission-driven organization, pioneering in industry cloud solutions for life sciences companies. As one of the fastest-growing SaaS companies, we have achieved over $2 billion in revenue and are committed...
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Strategic Consulting Lead for Life Sciences
3 weeks ago
Pleasanton, Kansas, United States Lifelancer Full timeOverviewLifelancer is a leading talent-hiring platform in Life Sciences, Pharma, and IT.CompensationThe estimated annual salary for this position is between $85,000 - $210,000. Please note that actual salaries may vary within the range above or below, depending on experience and location.Job DescriptionWe are seeking an experienced Engagement Manager to join...
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Senior Medical Systems Architect
2 weeks ago
Pleasanton, Kansas, United States Gateway Recruiting, INC. Full timeJob OverviewWe are seeking an experienced systems engineer to join our team at Gateway Recruiting, INC. as a Senior Medical Systems Architect for our Heart Failure portfolio.About the OpportunityThe ideal candidate will have 8+ years of experience in systems engineering and integration, system architecture, requirement/user need gathering, end-to-end...
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Product Monitoring Operations Lead
4 weeks ago
Pleasanton, Kansas, United States Calyxo Full timeUnleash Your Career with CalyxoCalyxo, a pioneering medical device company, is seeking an accomplished Product Monitoring Operations Lead to join our dynamic team in Pleasanton, California. As a leader in the field of kidney stone treatment, we're committed to empowering innovators who share our vision for a brighter future.We offer a competitive salary of...
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Pharmaceutical Consulting Manager
6 days ago
Pleasanton, Kansas, United States Lifelancer Full timeAbout the RoleThis position is ideal for a seasoned consulting professional with a strong background in pharmaceutical research and development. The successful candidate will have 8+ years of experience in a strategic/management consulting organization, with a proven track record of delivering high-impact engagements in regulatory, clinical, and safety...
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Quality Assurance Manager
4 weeks ago
Pleasanton, Kansas, United States KYYBA Full timeJob SummaryWe are seeking a Quality Assurance Manager to join our team at Kyyba. As a key member of our organization, you will be responsible for ensuring the highest quality standards in our products and services.About KyybaKyyba is a global leader in delivering high-quality resources and recruiting services. Founded in 1998, we have established a strong...
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Dry Utility Project Lead
4 days ago
Pleasanton, Kansas, United States Vizion Utility Partners Full timeResponsibilities:Coordinate project activities between clients, external teams, and internal stakeholders.Develop and implement project schedules to ensure timely completion.Manage project documentation, including submittals, tracking logs, and change orders.Communicate effectively with clients and utility business partners.Monitor project progress and...
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Pleasanton, Kansas, United States 1ST-RECRUIT LLC Full timeAbout the RoleWe are seeking an experienced Senior Azure Kubernetes Engineer to join our team at 1ST-RECRUIT LLC. This is a 5-day onsite opportunity with no remote work required.Job DescriptionThis position involves managing deployments on AKS clusters, upgrading and patching AKS clusters using Ansible or Terraform, securing AKS cluster service endpoints,...
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Project Development Consultant
4 days ago
Pleasanton, Kansas, United States Essel Full timeEssential ResponsibilitiesThis Environmental Project Engineer position involves conducting Phase I and II environmental site assessments, multi-media sampling, and report writing. You will also be responsible for project management, proposal preparation, and budgeting. Additionally, you will communicate project status and compliance issues with clients,...
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Lead Instrumentation Development Engineer
1 week ago
Pleasanton, Kansas, United States Calyxo Full timeAbout the PositionWe are seeking an accomplished Senior Engineering Manager to lead our Disposable Instruments Development Team. As a key member of our R&D department, you will be responsible for driving the design and development of advanced medical devices. The ideal candidate will have expertise in mechanism and control systems design, with experience in...
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Director of Advanced Engineering
5 days ago
Pleasanton, Kansas, United States Calyxo Full timeAt Calyxo, we're committed to fostering an environment where diversity and inclusion are valued and prioritized. We believe that diverse viewpoints bring diverse capabilities, which strengthen our focus and fuel our growth. As a visionary sensor systems lead, you'll be part of a dynamic team working in a fun, diverse atmosphere. With a compensation plan that...
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Utility Project Lead
4 days ago
Pleasanton, Kansas, United States Vizion Utility Partners Full timeJob DescriptionAs a Utility Project Lead, you will oversee the coordination between the client, external project team, public utility team, drafting team, and other project stakeholders. You will be responsible for setting priorities, preparing project schedules, and working on multiple projects in a team-based environment with a focus on delivery and...
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Senior Life Sciences Professional
6 days ago
Pleasanton, Kansas, United States Lifelancer Full timeLife Sciences Consultant Job DescriptionWe're seeking a highly skilled consultant to join our team as a Senior Life Sciences Professional. This role involves managing multiple project engagements, leading business development initiatives, and providing expert advice on regulatory, clinical, and safety matters.The successful candidate will have a strong...