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Fda Inspector Jobs in Naples, FL (NOW HIRING)

ARTHREX

Clinical Study Manager

Naples, FL · On-site

... inspections. * Keep management and Arthrex stakeholders informed on the progress of assigned ... Knowledge of ICH guidelines and FDA Regulations relevant to clinical studies is required.

Arthrex

Clinical Study Manager

Naples, FL · On-site

... inspections. * Keep management and Arthrex stakeholders informed on the progress of assigned ... Knowledge of ICH guidelines and FDA Regulations relevant to clinical studies is required.

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How much do fda inspector jobs pay per year?

As of Sep 5, 2026, the average yearly pay for fda inspector in Naples, FL is $51,743.00, according to ZipRecruiter salary data. Most workers in this role earn between $36,300.00 and $59,800.00 per year, depending on experience, location, and employer.

What does an FDA inspector do?

An FDA Inspector is responsible for ensuring that companies comply with federal regulations related to food, drugs, medical devices, and other products overseen by the U.S. Food and Drug Administration. They conduct inspections, review records, collect samples, and assess manufacturing practices to ensure public health and safety. Inspectors may also investigate complaints, issue compliance notices, and recommend enforcement actions if violations are found.

What skills and qualifications are needed to be an FDA inspector?

To thrive as an FDA Inspector, you need a solid background in science or public health, attention to detail, and thorough knowledge of regulatory standards, often supported by a relevant degree. Familiarity with inspection protocols, laboratory testing equipment, and digital reporting systems is commonly required, along with potential USDA or FDA certifications. Strong analytical thinking, effective communication, and integrity are important soft skills for this role. These competencies ensure accurate inspections, compliance with safety regulations, and clear reporting essential to public health and organizational accountability.

What types of facilities or products do FDA inspectors review, and what does a typical inspection process involve?

FDA Inspectors routinely examine a variety of facilities, such as food processing plants, pharmaceutical manufacturers, medical device companies, and cosmetic production sites, to ensure compliance with federal safety and quality regulations. A typical inspection involves reviewing operational procedures, examining production environments, sampling products, and interviewing staff to identify potential violations or risks. Inspectors often work onsite, sometimes with travel required to cover multiple locations within their region, and collaborate closely with facility management to explain findings and recommend corrective actions. This role offers the opportunity to make a significant impact on public health and provides clear advancement pathways into specialized inspection or supervisory roles within regulatory agencies.

How do you become an FDA inspector?

To become an FDA inspector, candidates typically need a bachelor's degree in a relevant field such as biology, chemistry, or food science, along with experience in food safety, pharmaceuticals, or related areas. They must pass a written exam and a background check, and often undergo specialized training at the FDA's training center. Certification or licensing is not required but can enhance prospects in the field.

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Fda Inspector jobs near you
Infographic showing various Fda Inspector job openings in Naples, FL as of August 2026, with employment types broken down into 86% Full Time, 11% Part Time, 2% Contract, and 1% Nights. Highlights an 99% Physical, and 1% Remote job distribution, with an average salary of $51,743 per year, or $24.9 per hour.

Clinical Study Manager

ARTHREX

Naples, FL • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 11 days ago

Arthrex rating

7.8

Company rating: 7.8 out of 10

Based on 77 frontline employees who took The Breakroom Quiz

170th of 545 rated manufacturers

Job description

Requisition ID:                       65832                          Title: Clinical Study Manager

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Clinical Study Manager to support clinical research studies. This individual will be responsible for assisting the study team in running the day to day operational activities within clinical studies. The ideal candidate would have experience managing clinical research studies from startup through closeout, overseeing site operations, CRO activities, data collection, investigational product management, and compliance across CTMS, eTMF, and EDC systems. They would also lead contract and budget negotiations, vendor onboarding, site training, and regulatory coordination while tracking timelines, milestones, and quality metrics to ensure successful study execution. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better.

This is an onsite position based at our global headquarters in Naples, Florida.

Essential Duties and Responsibilities:

  • Manage clinical research studies from intake through closeout.
  • Monitor the management of and collection of data.
  • Ensures compliance with the Clinical Trial Management System (CTMS), Electronic Trial Master (eTMF) filing, and Electronic Data Capture (EDC) systems, securing essential documents and quality-checking files and the EDC for accuracy and completeness.
  • Responsible for securing essential vendor documents for assigned clinical studies to assist in establishing accounts in A/P system within compliance guidelines.
  • Responsible for establishing accounts in billing systems within compliance guidelines and issuing payments to vendors and investigators according to executed agreements.
  • Lead clinical trial agreement negotiations to ensure efficient and timely processing of clinical trial agreements.
  • Provides oversight for Contract Research Organizations (CRO) activities.
  • Lead clinical budget negotiations for the purpose of executing a clinical study.
  • Tracks study status, enrollment, regulatory documentation, and site start-up status and communicates status with the study sites.
  • Track and report on the progress of assigned clinical studies, including budget and timelines.
  • Responsible for ordering, distributing, and receiving investigational products.
  • Assists in user acceptance testing in the EDC and eTMF; evaluates new database updates.
  • Assists with the preparation of technical reports, summaries, templates, and protocols.
  • Oversee data collection compliance via tracked milestones.
  • Orders, distributes and tracks study supplies and assists the study team in developing study-related documents.
  • Maintains all pertinent study correspondences between the sponsor, study sites, and third parties.
  • Develops clinical research standard operating procedures and work instructions.
  • Coordinate and lead Investigational site training and meetings.
  • Identify and mitigate quality risk and/or issues associated with assigned studies/activities.
  • Assist site coordinators with IRB submissions as necessary.
  • Ensure operational aspects of the studies being conducted in accordance with all relevant ethical and government standards, GCP's, and Standard Operating Procedures.
  • Participate in the preparation and follow-up of internal process audits, vendor and study site quality auditis as well as regulatory inspections.
  • Keep management and Arthrex stakeholders informed on the progress of assigned clinical study metrics and other project-related information. Specifically, costs, timelines, milestones, and other pertinent metrics.

Knowledge and Skill Requirements/Specialized Courses and/or Training:

  • Knowledge of ICH guidelines and FDA Regulations relevant to clinical studies is required. 
  • Clinical Research Certification is required or obtained in one year.
  • Comprehension of medical terminology or can reference literature for understanding.
  • Proficient software skills: Word/ Excel/PowerPoint/database.
  • A combination of education, experience, and RA influence may be considered.

Education and Experience:

  • Bachelor's degree in health, life sciences or other relevant field of study + 4 years of Clinical Research experience required OR Master's Degree + 5 years experience.
  • Pre-market IDE or IND study experience preferred.
  • One year of industry-sponsored or CRO employment is required.

Machine, Tools, and/or Equipment Skills:

  • PC, database, research tools, internet research tools.

Arthrex Benefits

  • Medical, Dental and Vision Insurance
  • Company-Provided Life Insurance
  • Voluntary Life Insurance
  • Flexible Spending Account (FSA)
  • Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
  • Matching 401(k) Retirement Plan
  • Annual Bonus
  • Wellness Incentive Program
  • Free Onsite Medical Clinics
  • Free Onsite Lunch
  • Tuition Reimbursement Program
  • Trip of a Lifetime
  • Paid Parental Leave
  • Paid Time Off
  • Volunteer PTO
  • Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.

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