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Iso 13485 Jobs (NOW HIRING)

BSI Group

ISO 18081,000 1901ISO90 ISO 13485 QMS （MUST） （） ＊ （） ＊ （） （WANT） / ＊ＢＳＩ ：（） ＊ISO13485 ：9：00～17：30（60） ：14（） ： ：（1）（60） Medical ...

BSI Prof Serv EHS West

ISO 18081,000 1901ISO90 ISO 13485 QMS （MUST） （） ＊ （） ＊ （） （WANT） / ＊ＢＳＩ ：（） ＊ISO13485 ：9：00～17：30（60） ：14（） ： ：（1）（60） Medical ...

DivIHN Integration Inc

Quality Manager

Oneonta, NY · On-site

This facility is undergoing a Quality System Transformation from ISO 9001 to ISO 13485. Looking for minimum of 2 years Project Management experience with managing this type of transition. ETQ ...

Zenni Optical

Quality Supervisor

Obetz, OH · On-site

Position Summary The Quality Supervisor is responsible for leading quality operations within an ISO 13485-certified optical manufacturing laboratory. This role has initial responsibility to support ...

Zenni Optical

Be Seen First

Quality Supervisor

Obetz, OH · On-site

$69K - $85K/yr

Breakage Department Management (ISO 13485 Aligned) * Ensure proper identification, segregation, documentation, and disposition of nonconforming product. * Maintain full traceability and data ...

Zenni Optical

Quality Supervisor

Obetz, OH · On-site

Position Summary The Quality Supervisor is responsible for leading quality operations within an ISO 13485-certified optical manufacturing laboratory. This role has initial responsibility to support ...

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Iso 13485 information

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How much do iso 13485 jobs pay per hour?

As of Jun 16, 2026, the average hourly pay for iso 13485 in the United States is $21.09, according to ZipRecruiter salary data. Most workers in this role earn between $18.27 and $21.63 per hour, depending on experience, location, and employer.

What are the typical day-to-day responsibilities of someone working in an ISO 13485 quality assurance role?

Professionals in an ISO 13485 quality assurance role are typically responsible for developing, implementing, and maintaining quality management systems specific to medical devices. Their daily tasks include preparing documentation, conducting internal audits, ensuring compliance with regulatory standards, managing nonconformances, and coordinating corrective actions. They often collaborate closely with engineering, manufacturing, and regulatory affairs teams to address quality issues and facilitate continuous improvement. This position involves significant attention to detail and communication to uphold the organization’s quality objectives and regulatory commitments.

What is an ISO 13485 job?

An ISO 13485 job typically involves roles in quality management, regulatory compliance, and manufacturing within the medical device industry. Professionals in these roles ensure that companies adhere to ISO 13485, the international standard for quality management systems in medical devices. Responsibilities may include managing audits, maintaining documentation, overseeing regulatory compliance, and improving quality processes. These jobs are crucial for ensuring product safety, consistency, and compliance with regulatory requirements.

What are the key skills and qualifications needed to thrive in the Iso 13485 position, and why are they important?

To thrive in an ISO 13485 role, you need a strong understanding of quality management systems for medical devices, regulatory requirements, and risk management principles, often supported by a background in engineering, life sciences, or quality assurance. Familiarity with audit processes, CAPA (Corrective and Preventive Action) systems, and certifications like Certified Quality Auditor (CQA) or ISO 13485 Lead Auditor are highly valued. Attention to detail, problem-solving abilities, and effective communication set outstanding candidates apart. These skills ensure compliance with stringent regulations and help maintain product quality and patient safety in the medical device industry.

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Iso 13485 jobs near you
Infographic showing various Iso 13485 job openings in the United States as of June 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $43,861 per year, or $21.1 per hour.

FDA Consultant (ISO 13485 & ISO 22716 Experience)

IMSM

Manhattan, NY • On-site

Contractor

Posted 17 days ago

Job description

Freelance FDA Consultant (ISO 13485 & ISO 22716 Experience)
USA Remote (with occasional on-site client visits)
Contract / Self-Employed Basis
About IMSM
IMSM (International Management Systems Marketing) is a global force in ISO consultancy - helping organisations not just achieve certification, but transform the way they operate. We partner with businesses across every sector, elevating performance, boosting compliance and unlocking measurable competitive advantage.
Now part of the Axiom GRC division within the WorkNest group and backed by Inflexion, we bring the reach and resources of a worldwide organisation. With teams spanning the UK, Europe, North America, APAC, Africa and Canada - and a growing network of 85 employees and more than 350 expert contractors enables us to deliver high-quality, results-driven ISO consultancy to clients worldwide.
The Opportunity
We are seeking an experienced FDA Consultant to support regulatory compliance, quality system development, and market readiness activities. The ideal candidate will have deep expertise in FDA regulations alongside hands-on experience implementing and auditing quality systems aligned with ISO 13485 (medical devices) and ISO 22716 (cosmetics GMP).
What You Will Do
  • Provide strategic guidance on FDA regulatory requirements, including submissions, compliance, and inspections
  • Lead or support FDA submissions (e.g., 510(k), cosmetic product compliance, facility registrations)
  • Develop, implement, and maintain Quality Management Systems (QMS) compliant with ISO 13485 and ISO 22716
  • Conduct gap analyses and internal audits to assess compliance readiness
  • Support preparation for FDA inspections and notified body audits
  • Review and author SOPs, technical documentation, and quality records
  • Advise on risk management processes and product lifecycle compliance
  • Ensure alignment between US FDA regulations and international standards
  • Train internal teams on regulatory requirements and quality standards
  • Liaise with regulatory authorities and external stakeholders as needed and have expertise in management systems and relevant standards

What You Will Bring
  • Proven experience as an FDA consultant or regulatory affairs specialist
  • Strong knowledge of FDA regulations (e.g., 21 CFR Parts 210, 211, 820, and cosmetics regulations)
  • RAC (Regulatory Affairs Certification) or equivalent
  • Demonstrated experience with:
    • ISO 13485 (Medical Devices Quality Management Systems)
    • ISO 22716 (Cosmetic Good Manufacturing Practices)
  • Experience supporting FDA inspections and/or notified body audits
  • Excellent documentation, communication, and analytical skills

Join Our Global Contractor Community
As part of the WorkNest group and the wider Axiom GRC division, you will contribute to a powerful network of more than 800 experts shaping the future of Governance, Risk and Compliance services.
If you are a dedicated ISO professional looking for flexible, rewarding work with a market leading consultancy, we would love to hear from you.
Department Operations Locations USA Remote Remote status Hybrid Employment type Contract

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