... device, biologic, behavioral, and observational studiesDetermine regulatory pathway for each study, including IND, IDE, exempt, abbreviated, or non-FDA regulated statusOversee preparation and ...
... device, biologic, behavioral, and observational studiesDetermine regulatory pathway for each study, including IND, IDE, exempt, abbreviated, or non-FDA regulated statusOversee preparation and ...
... device, biologic, behavioral, and observational studies Determine regulatory pathway for each study, including IND, IDE, exempt, abbreviated, or non-FDA regulated status Oversee preparation and ...
... device, biologic, behavioral, and observational studies Determine regulatory pathway for each study, including IND, IDE, exempt, abbreviated, or non-FDA regulated status Oversee preparation and ...
Biomedical Engineering Tutor
Scottsdale, AZ · Remote
$18 - $40/hr
Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...
Biomedical Engineering Tutor
Scottsdale, AZ · Remote
$18 - $40/hr
Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...
Biomedical Engineering Tutor
Tempe, AZ · Remote
$18 - $40/hr
Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...
Biomedical Engineering Tutor
Tempe, AZ · Remote
$18 - $40/hr
Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...
Biomedical Engineering Tutor
Mesa, AZ · Remote
$18 - $40/hr
Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...
Biomedical Engineering Tutor
Mesa, AZ · Remote
$18 - $40/hr
Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...
Biomedical Engineering Tutor
Phoenix, AZ · Remote
$18 - $40/hr
Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...
Biomedical Engineering Tutor
Phoenix, AZ · Remote
$18 - $40/hr
Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...
Biomedical Engineering Tutor
Tucson, AZ · Remote
$18 - $40/hr
Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...
Biomedical Engineering Tutor
Tucson, AZ · Remote
$18 - $40/hr
Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...
Biomedical Engineering Tutor
Gilbert, AZ · Remote
$18 - $40/hr
Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...
Biomedical Engineering Tutor
Gilbert, AZ · Remote
$18 - $40/hr
Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...
Biomedical Engineering Tutor
Glendale, AZ · Remote
$18 - $40/hr
Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...
Biomedical Engineering Tutor
Glendale, AZ · Remote
$18 - $40/hr
Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...
Biomedical Engineering Tutor
Chandler, AZ · Remote
$18 - $40/hr
Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...
Biomedical Engineering Tutor
Chandler, AZ · Remote
$18 - $40/hr
Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...
Master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution. * Experience in FDA regulated industries. * Knowledge of ...
Master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution. * Experience in FDA regulated industries. * Knowledge of ...
Administers prescribed intravenous and subcutaneous medications and biologics, adhering to prescriber order and applicable FDA dosing parameters * Evaluates the effectiveness of the health care ...
Administers prescribed intravenous and subcutaneous medications and biologics, adhering to prescriber order and applicable FDA dosing parameters * Evaluates the effectiveness of the health care ...
Administers prescribed intravenous and subcutaneous medications and biologics, adhering to prescriber order and applicable FDA dosing parameters * Evaluates the effectiveness of the health care ...
Administers prescribed intravenous and subcutaneous medications and biologics, adhering to prescriber order and applicable FDA dosing parameters * Evaluates the effectiveness of the health care ...
Administers prescribed intravenous and subcutaneous medications and biologics, adhering to prescriber order and applicable FDA dosing parameters * Evaluates the effectiveness of the health care ...
Administers prescribed intravenous and subcutaneous medications and biologics, adhering to prescriber order and applicable FDA dosing parameters * Evaluates the effectiveness of the health care ...
Administers prescribed intravenous and subcutaneous medications and biologics, adhering to prescriber order and applicable FDA dosing parameters * Evaluates the effectiveness of the health care ...
Administers prescribed intravenous and subcutaneous medications and biologics, adhering to prescriber order and applicable FDA dosing parameters * Evaluates the effectiveness of the health care ...
Administers prescribed intravenous and subcutaneous medications and biologics, adhering to prescriber order and applicable FDA dosing parameters * Evaluates the effectiveness of the health care ...
Administers prescribed intravenous and subcutaneous medications and biologics, adhering to prescriber order and applicable FDA dosing parameters * Evaluates the effectiveness of the health care ...
Master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution. * Experience in FDA regulated industries. * Knowledge of ...
Master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution. * Experience in FDA regulated industries. * Knowledge of ...
Master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution. * Experience in FDA regulated industries. * Knowledge of ...
Master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution. * Experience in FDA regulated industries. * Knowledge of ...
Evaluates and solves problems related to collection and processing of biological specimens ... Ensures compliance with rules and regulations of assorted regulatory agencies such as CAP, FDA, JC ...
Evaluates and solves problems related to collection and processing of biological specimens ... Ensures compliance with rules and regulations of assorted regulatory agencies such as CAP, FDA, JC ...
Quality Assurance Specialist II
Phoenix, AZ · On-site
$60K/yr
Bachelor's degree, preferably in Chemistry or in physical or biological science. * Minimum 3 years experience in a Food and Drug Administration (FDA) regulated manufacturing environment. * Minimum 1 ...
Quick apply
Quality Assurance Specialist II
Phoenix, AZ · On-site
$60K/yr
Bachelor's degree, preferably in Chemistry or in physical or biological science. * Minimum 3 years experience in a Food and Drug Administration (FDA) regulated manufacturing environment. * Minimum 1 ...
Fda Biologist information
See Arizona salary details
$34.5K - $43K
6% of jobs
$43K - $51.6K
9% of jobs
$56.7K is the 25th percentile. Wages below this are outliers.
$51.6K - $60.1K
17% of jobs
$60.1K - $68.7K
13% of jobs
The median wage is $73.5K / yr.
$68.7K - $77.3K
10% of jobs
$77.3K - $85.8K
7% of jobs
$85.8K - $94.4K
12% of jobs
$97.6K is the 75th percentile. Wages above this are outliers.
$94.4K - $102.9K
4% of jobs
$102.9K - $111.5K
4% of jobs
$111.5K - $120K
1% of jobs
$120K - $128.6K
17% of jobs
$34.5K
$83.3K
$128.6K
How much do fda biologist jobs pay per year?
What are the typical daily responsibilities of an FDA biologist?
An FDA Biologist’s daily tasks often include reviewing scientific data, conducting laboratory experiments, and preparing reports on biological product submissions. You may assess the safety and efficacy of products such as vaccines or medical devices, ensuring compliance with regulatory standards. Collaboration with interdisciplinary teams—including chemists, statisticians, and regulatory affairs specialists—is common to address scientific questions and support regulatory decision-making. The role also involves staying updated on scientific advancements and regulatory changes relevant to the field. This dynamic environment provides opportunities to contribute to public health while developing specialized expertise.
What are the key skills and qualifications needed to thrive in the FDA biologist position, and why are they important?
To thrive as an FDA Biologist, you need a degree in biology or a related scientific field, strong analytical and laboratory skills, and a solid understanding of regulatory requirements. Familiarity with laboratory instruments, scientific data analysis tools, and regulatory databases such as GLP (Good Laboratory Practice) systems is important. Attention to detail, effective communication, and strong problem-solving abilities are valuable soft skills in this role. These competencies are crucial for accurately evaluating biological data, ensuring regulatory compliance, and collaborating effectively within multidisciplinary teams at the FDA.
What is an FDA biologist?
An FDA Biologist is a scientist who evaluates biological products, research data, and laboratory studies to ensure public health and safety. They work on regulatory reviews, inspections, and policy development related to vaccines, gene therapy, blood products, and other biologics. Their role helps ensure compliance with federal regulations and supports scientific advancements in healthcare.

Manager Sponsor Regulatory Affairs & Institutional Trial Compliance
Scottsdale, AZ • On-site
Full-time
Posted 22 days ago
HonorHealth rating
7.7
Based on 209 frontline employees who took The Breakroom Quiz
158th of 887 rated healthcare providers
Job description
Primary City/State:
Shea Medical Office Building - 10197 N 92nd St Scottsdale, AZ 85258Category:
Research OperationsShift:
DayDepartment:
HRI-Translational ResearchMonday-Friday
Great care starts with great people. (Like you.)
At HonorHealth, you'll find something special. From humble beginnings in 1927 to one of Arizona's largest nonprofit healthcare systems, our culture is built on warmth and neighborly kindness. Behind every smile is a highly skilled professional with deep expertise and an unwavering dedication to what matters most - caring for the health and well-being of people and communities across the greater Phoenix area.
Responsibilities:
- Sponsor Regulatory Strategy and Agency Compliance:Lead implementation of regulatory strategy for institutionally sponsored clinical trials, including drug, device, biologic, behavioral, and observational studiesDetermine regulatory pathway for each study, including IND, IDE, exempt, abbreviated, or non-FDA regulated statusOversee preparation and submission of INDs, IDEs, amendments, annual reports, safety reports, protocol changes, and closeout filings as requiredServe as primary institutional contact with FDA and other regulatory agencies regarding sponsor mattersMonitor changes in regulations, guidance, and enforcement trends, then implement required operational changesEnsure fulfillment of sponsor commitments, reporting deadlines, and regulatory obligationsProvides guidance to leadership on regulatory risk, escalation items, and remediation strategy.
- Trial Startup, Lifecycle Management, and Sponsor Oversight:Lead sponsor regulatory and compliance startup processes from concept approval through study activationOversee regulatory readiness for protocol finalization, informed consent documents, investigator qualifications, site documents, and essential regulatory recordsApprove activation of internal and external participating sites once sponsor requirements are metDirect amendment implementation processes across all participating sitesOversee study closeout, final reporting, archival readiness, and record retention requirementsSupport expansion of institutional trials into multi-site networks and affiliated partnersEnsure delegation of sponsor responsibilities to CROs, monitors, vendors, or external partners is documented and controlledEnsure trial institutional reporting requirements such as to CT.Gov, registration and reporting are completed within the institutional regulatory guidelines.
- Safety Oversight, Quality Systems, and Inspection Readiness:Establish sponsor systems for adverse event review, serious adverse event reporting, unanticipated problem management, and safety signal escalationCoordinate oversight bodies such as DSMBs, independent medical monitors, adjudication committees, and safety review committees when requiredMaintain sponsor Trial Master File standards, completeness, version control, and inspection readinessEnsure regulatory data fields are complete in electronic research support systemPartner with Data Manager to conduct IND/IDE tracking and create reporting dashboardsPartner with Quality Assurance, Compliance, IRB, and operational leaders on audits, monitoring findings, CAPAs, and corrective actionsLead internal audit readiness program and conduct mock FDA inspectionsLead preparation for FDA inspections, sponsor audits, and external regulatory reviewsIdentify systemic compliance risks and implement preventive controls
- Governance, Policy, Training, and Enterprise Collaboration:Develop and maintain sponsor SOPs, work instructions, templates, governance charters, and operational standardsCreate standardized pathways for investigator initiated and institutionally sponsored trialsEducate investigators, research staff, executives, and operational departments on sponsor obligations and regulatory expectationsPartner with IRB, legal, contracting, finance, pharmacy, laboratory, privacy, data governance, and revenue cycle teams to align study operationsAdvise investigators on regulatory and institutional compliance documentation needs during protocol development to improve feasibility and regulatory successPromote a culture of accountability, service, compliance, and operational excellence across the research enterprise
- Leadership, Talent Management, and Financial Stewardship:Build, lead, mentor, and evaluate a high performing sponsor regulatory affairs teamEstablish staffing models aligned with institutional trial volume and complexityWork with project coordinators to set performance metrics for study startup timelines, as it pertains to regulatory and compliance documentationDevelop and manage departmental operating and capital budgetsIdentify efficiencies, automation opportunities, and scalable systems that improve productivity and reduce cycle timesProvide regular dashboards and strategic updates to executive leadershipSupport long term growth of the institutional sponsored trial portfolio
- Bachelors Required
- Masters in health administration, public health, regulatory science, business, nursing, pharmacy, law, or related field Preferred
- 6 years, of progressive clinical research experience Required
- 3 years, of leadership experience in regulatory affairs, sponsor operations, quality systems, or clinical trial administration Required
- 3 years, of experience with IND, IDE, FDA submissions, or sponsor held trials Preferred
- 3 years, of experience building teams, systems, and operational infrastructure Preferred
- Society of Clinical Research Associates CCRP Preferred
- Association of Clinical Research Professionals CCRC Preferred
- Regulatory Affairs Professionals Society RAC Preferred
- PMP Preferred
We're all in for your career.
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About HonorHealth
Sourced by ZipRecruiter
HonorHealth is a non-profit, local community healthcare system serving an area of 1.6 million people in the greater Phoenix area. The network encompasses six acute-care hospitals, an extensive medical group, outpatient surgery centers, a cancer care network, clinical research, medical education, a foundation, and community services with approximately 13,100 team members, 3,500 affiliated providers and nearly 700 volunteers. HonorHealth was formed by a merger between Scottsdale Healthcare and John C. Lincoln Health Network. HonorHealth's mission is to improve the health and well-being of those we serve.
Industry
Health care and social assistance
Company size
10,000+ Employees
Headquarters location
Scottsdale, AZ, US
Year founded
2014