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Fda Inspector Jobs in New York (NOW HIRING)

Mativ Holdings, Inc.

Manager - Quality

Orangeburg, NY · On-site

Substantial front room experience of FDA Inspections and Certification Body Audits Preferred * Lean Six Sigma Green Belt Certification Competencies * Demonstrated ability to manage a Quality team in ...

Mativ

Manager - Quality

Orangeburg, NY · On-site

Substantial front room experience of FDA Inspections and Certification Body Audits Preferred * Lean Six Sigma Green Belt Certification Competencies * Demonstrated ability to manage a Quality team in ...

InspireMD

Field Clinical Specialist

Morristown, NJ · Remote

$80K - $87K/yr

Support FDA inspections and audits, ensuring that all regulatory and complaint handling documentation is in order and facilitating smooth interactions with regulatory authorities. Qualifications:

Montefiore

PROGRAM DIRECTOR CCTO (JR227774)

Bronx, NY · On-site

Prepare for NIH, BRANY and Sponsor audits and FDA inspections. * Serve on departmental and institutional committees as necessary. * Other duties as assigned. Requirements * Master's degree in Life ...

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Fda Inspector information

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$26.8K

$60.1K

$108.3K

How much do fda inspector jobs pay per year?

As of Sep 6, 2026, the average yearly pay for fda inspector in New York is $60,105.00, according to ZipRecruiter salary data. Most workers in this role earn between $42,100.00 and $69,500.00 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.

What are the most commonly searched types of Fda Inspector jobs in New York?

The most popular types of Fda Inspector jobs in New York are:

What are popular job titles related to Fda Inspector jobs in New York?

For Fda Inspector jobs in New York, the most frequently searched job titles are:

What job categories do people searching Fda Inspector jobs in New York look for?

The top searched job categories for Fda Inspector jobs in New York are:

What cities in New York are hiring for Fda Inspector jobs?

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Fda Inspector jobs near you
Infographic showing various Fda Inspector job openings in New York as of August 2026, with employment types broken down into 89% Full Time, and 11% Contract. Highlights an 78% In-person, and 22% Remote job distribution, with an average salary of $60,105 per year, or $28.9 per hour.

Director, Quality Systems & Regulatory Affairs (Remote - East Coast)

CEFALY Technology

Darien, CT • On-site, Remote

$160K - $180K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 2 days ago

Job description

Director, Quality Systems & Regulatory Affairs
Department: Quality & Regulatory Affairs
Reports To: SVP, Operations
Location: Remote or Hybrid - East Coast ONLY
FLSA Status: Exempt, Full-Time
Position Summary
CEFALY Technology is seeking an experienced Quality Systems & Regulatory Affairs leader to strengthen and scale the organization's quality and regulatory infrastructure. This individual will serve as the functional lead for Quality Systems and Regulatory Affairs and will be responsible for improving organizational compliance, strengthening audit readiness, and reducing quality system risk through robust process ownership and execution.
A critical priority for this role will be optimizing and expanding the company's electronic Quality Management System (eQMS), conducting comprehensive assessments of quality documentation and system effectiveness, and driving sustainable process improvements across the organization. This position will provide experienced leadership during notified body audits and regulatory inspections and will help build long-term organizational capability through mentorship and process maturity.
The role serves as a strategic and hands-on partner across Operations, Supply Chain, Customer Service, Product Development, and leadership teams to ensure compliance excellence and scalable growth.
Essential Responsibilities
Quality Management System (QMS) & eQMS Leadership
  • Serve as system owner and business lead for the organization's eQMS platform including optimization, implementation expansion, workflow design, governance, and user adoption.
  • Assess current eQMS utilization and develop a roadmap for full implementation and process maturity.
  • Own and administer day-to-day QMS and eQMS activities and processes.
  • Lead continual improvement initiatives across quality system processes and documentation.
  • Lead comprehensive audits of controlled documentation and quality records to identify inconsistencies, gaps, obsolete content, and systemic documentation deficiencies.
  • Establish processes and controls ensuring consistency across SOPs, work instructions, forms, labels, templates, and quality records.
  • Drive document control processes including creation, revision workflows, review cycles, training assignments, archival activities, and change management.
  • Develop sustainable document governance practices to reduce repeat nonconformances and improve inspection readiness.
  • Monitor quality metrics and identify opportunities for process improvements.
  • Support and improve CAPA, nonconformance, complaint handling, change control, risk management, and supplier quality processes.
  • Ensure QMS alignment with ISO 13485, FDA Quality System Regulation (21 CFR Part 820/QMSR), EU MDR, and applicable global requirements.
  • Lead initiatives to improve quality system effectiveness, data integrity, and organizational compliance maturity.
  • Maintain ongoing inspection and audit readiness.

Audit & Compliance Leadership
  • Act as primary Quality and Regulatory lead during notified body audits, FDA inspections, supplier audits, and external quality assessments.
  • Lead audit preparation strategy, evidence collection, coordination activities, and response management.
  • Drive audit finding remediation through root cause analysis and sustainable CAPA implementation.
  • Support management review processes and quality reporting.
  • Maintain a continuous state of organizational inspection readiness.

Regulatory Affairs Leadership
  • Independently lead FDA and international regulatory submissions and agency interactions.
  • Prepare, coordinate, and execute regulatory filings and lifecycle submissions.
  • Conduct regulatory impact assessments related to product, process, manufacturing, supplier, labeling, and operational changes.
  • Provide regulatory strategy recommendations and communicate business impact to leadership.
  • Support registrations, renewals, amendments, and post-market regulatory activities.
  • Interpret changing regulatory requirements and proactively communicate implications.
  • Maintain regulatory records and submission archives.

Leadership & Cross-Functional Partnership
  • Mentor and help develop junior QA/RA personnel.
  • Provide quality and regulatory leadership across Operations, Supply Chain, Customer Service, Product Development, and leadership teams.
  • Act as an internal subject matter expert for QMS and regulatory requirements.
  • Support employee training initiatives related to quality systems and compliance.
  • Provide guidance during business, operational, and product decisions.

Qualifications
Education
  • Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or related field required.
  • Advanced degree preferred.

Experience
  • 8-12+ years of progressive Quality and Regulatory Affairs experience within medical devices.
  • Demonstrated experience serving as lead quality or regulatory representative during notified body audits and regulatory inspections.
  • Proven experience owning, implementing, or significantly improving an electronic QMS platform; Greenlight Guru experience strongly preferred.
  • Demonstrated experience identifying and remediating systemic documentation and quality system deficiencies.
  • Experience independently leading FDA submissions and EU MDR activities.
  • Experience with CAPA, complaint handling, risk management, supplier quality, document control, and change management systems.
  • Demonstrated success improving audit outcomes and quality system maturity.
  • Prior people leadership or mentoring experience strongly preferred.
  • Experience supporting Class II and/or Class III medical devices preferred.

Knowledge & Skills
  • Deep understanding of ISO 13485, FDA Quality System Regulation (21 CFR Part 820/QMSR), EU MDR, and related global regulations.
  • Strong understanding of quality systems architecture and eQMS administration.
  • Excellent technical writing and documentation skills.
  • Strong project management and organizational capabilities.
  • Strong leadership presence during audits and external interactions.
  • Ability to manage multiple priorities within fast-paced environments.
  • Excellent communication and cross-functional influencing skills.
  • Strong analytical, problem-solving, and systems-thinking abilities.

Preferred Certifications
  • RAC, CQE, CQA, ASQ certifications, or equivalent preferred.

Success in this role includes:
  • Complete a comprehensive assessment of current QMS and eQMS state.
  • Develop and execute a Greenlight Guru optimization roadmap.
  • Conduct a full controlled-document audit and remediation initiative.
  • Reduce repeat audit observations and documentation inconsistencies.
  • Improve notified body audit readiness and inspection confidence.
  • Strengthen quality system governance and documentation control processes.
  • Improve organizational QA/RA capability and mentorship support.
  • Build scalable infrastructure supporting future growth.

Why This Role Matters
This role is being added to strengthen organizational quality and regulatory capabilities, reduce single-point dependency risk, improve QMS sustainability, and establish scalable systems supporting long-term growth and compliance excellence.
Benefits
  • Health insurance (80% employer-paid)
  • Employer-paid Dental and Vision
  • Short-Term and Long-Term Disability
  • Group Life Insurance
  • IRA with company match (no vesting period)
  • Paid PTO
  • Paid company holidays

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