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Iso Certification Body Jobs (NOW HIRING)

Supplying can makers with Cupping, Body making, Trimming, Decorating, Bottom Rim Coating, Necking ... ASQ Certification is preferred. * Excellent oral and written communication skills and demonstrated ...

Supplying can makers with Cupping, Body making, Trimming, Decorating, Bottom Rim Coating, Necking ... ASQ Certification is preferred. * Excellent oral and written communication skills and demonstrated ...

Lead the company through initial ISO 9001 certification, including selection and management of the external certification body * Own all QMS documentation: quality manual, SOPs, work instructions ...

Join Anatometal, a leading name in body jewelry manufacturing located in beautiful Santa Cruz, CA ... ISO- certified environment. • Excellent color aptitude. • Proficiency in using precision ...

Quality Engineer

Middlefield, OH · On-site

$64K - $83K/yr

Support external audits (customer, corporate, certification body). Corrective Action & Problem ... Working knowledge of ISO 9001 and internal audit processes. * Experience with SPC, control charts ...

Serve as the point of contact for customer or Certification Body audits. Lead and/or assign ... Working knowledge of API quality and product standards, ISO-9000 series of quality system standards ...

Quality Engineer

Middlefield, OH · On-site

$64K - $83K/yr

Support external audits (customer, corporate, certification body). Corrective Action & Problem ... Working knowledge of ISO 9001 and internal audit processes. * Experience with SPC, control charts ...

Auditing techniques (ISO 9001, 14001, and/or OHSAS 18001 Lead Auditor Course, internal auditor ... Previous certification as an auditor from a recognized national or international certification body.

Serve as the point of contact for customer or Certification Body audits. Lead and/or assign ... Working knowledge of API quality and product standards, ISO-9000 series of quality system standards ...

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Iso Certification Body information

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$48

How much do iso certification body jobs pay per hour?

As of Jun 16, 2026, the average hourly pay for iso certification body in the United States is $27.62, according to ZipRecruiter salary data. Most workers in this role earn between $19.95 and $31.97 per hour, depending on experience, location, and employer.

What is an ISO Certification Body?

An ISO Certification Body is an independent organization that is authorized to assess and certify businesses or organizations against international ISO standards, such as ISO 9001 for quality management systems. These bodies conduct audits to verify that a company’s processes and systems meet the requirements set by the relevant ISO standard. If the company meets all criteria, the certification body issues an official certificate indicating compliance. ISO Certification Bodies themselves must be accredited to ensure impartiality and competence in carrying out assessments. Choosing a reputable certification body is important for the credibility of the ISO certification.

What are the main challenges faced by professionals working at an ISO certification body?

Professionals at an ISO certification body often face the challenge of balancing strict adherence to international standards with the unique needs of each client organization. They must stay current with frequent updates to ISO standards and ensure that all audits and certifications are impartial and thorough. Maintaining clear communication and documentation across diverse industries, as well as managing tight audit schedules, are also common aspects of the role. Collaboration with clients and internal teams is essential to ensure the certification process is smooth and transparent.

What are the key skills and qualifications needed to thrive as an ISO Certification Body professional, and why are they important?

To thrive as an ISO Certification Body professional, you need in-depth knowledge of ISO standards, auditing principles, and quality management systems, often backed by relevant certifications like ISO Lead Auditor. Familiarity with audit management software, documentation tools, and compliance tracking systems is typically required. Strong analytical thinking, attention to detail, and effective communication skills are crucial for building client trust and ensuring accurate assessments. These skills are essential for maintaining high certification standards, upholding organizational credibility, and supporting client compliance.

What is the difference between Iso Certification Body vs ISO Auditor?

AspectISO Certification BodyISO Auditor
CredentialsAccredited certification body, often with specific accreditationCertified auditor, often with ISO auditor certification
Work EnvironmentConducts certification audits, issues certificatesPerforms audits, assesses compliance during audits
Employer & Industry UsageCertification bodies, accreditation agenciesConsulting firms, organizations seeking certification

The main difference is that an ISO Certification Body is an organization authorized to issue ISO certificates after thorough audits, while an ISO Auditor is an individual who conducts those audits. Certification bodies oversee the certification process, whereas auditors perform the assessments to verify compliance with ISO standards.

Infographic showing various Iso Certification Body job openings in the United States as of June 2026, with employment types broken down into 1% Locum Tenens, 57% Full Time, 14% Part Time, 27% Contract, and 1% Nights. Highlights an 98% Physical, and 2% Remote job distribution, with an average salary of $57,455 per year, or $27.6 per hour.

Regulatory Affairs Specialist

Broadata Communications

Torrance, CA • On-site

$120K - $150K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 20 days ago


Job description

Regulatory Affairs Specialist
Broadata Communications, Inc. (BCI) – Torrance, CA
On-site
Company Overview
Broadata Communications, Inc. (BCI) is a privately held California-based corporation. BCI is a leading and innovative company specializing in the development of market-driven products for the transmission of digital multimedia (video, audio, and data) over fiber.  Our clients are world leaders in their industries, spanning entertainment, broadcast, medical, professional audio/video, house of worship, education, government, military, and transportation sectors.  We are ISO 13485 and ISO 9001 certified, with a strong commitment to quality, innovation, and continuous improvement.
Job Summary
Broadata Communications, Inc. is seeking a Regulatory Affairs Specialist to support the company’s medical device compliance activities, regulatory documentation, and quality system requirements. This role will support Class I and Class II medical device programs, including technical documentation, design history files, change control, risk management, supplier documentation, labeling review, customer regulatory requests, and audit readiness.
The ideal candidate has hands-on experience working in an FDA-regulated and ISO 13485 environment, with a strong understanding of Class I medical device requirements. Experience with Class II medical devices, 510(k) support, IEC 60601-1, EU MDR technical documentation, or customer-driven regulatory submissions is highly preferred.
This is an excellent opportunity for a detail-driven professional who thrives in a high-tech manufacturing environment and values teamwork, accountability, and continuous improvement.  This critical, hands-on role is based in Torrance, CA.  We offer a fast-paced, high impact and stimulating work environment with opportunities for professional growth and development within BCI.  Veterans welcome!
This is a hands-on position.  This is NOT a remote or hybrid position.
Key Responsibilities
  • Support regulatory compliance activities for medical device products manufactured or supported by Broadata.
  • Maintain and update regulatory documentation for Class I medical devices; support Class II documentation where applicable.
  • Assist with Design History Files, Device Master Records, Technical Files, and regulatory evidence packages.
  • Support FDA 21 CFR Part 820 / QMSR transition activities, ISO 13485 compliance, and customer-specific regulatory requirements.
  • Review and approve product labeling, IFUs, specifications, drawings, procedures, and quality records for regulatory compliance.
  • Support risk management files in accordance with ISO 14971, including hazard analysis, risk controls, and traceability.
  • Assist with change control assessments to determine regulatory impact.
  • Support internal audits, external audits, customer audits, and certification body audits.
  • Work cross-functionally with Quality, Engineering, Manufacturing, Supply Chain, and Program Management to ensure regulatory requirements are understood and implemented.
  • Support EU MDR, FDA, and international regulatory documentation requests as needed.
  • Assist in preparing regulatory responses, customer questionnaires, compliance letters, and technical documentation packages.
  • Maintain awareness of applicable standards, regulations, and guidance documents.
  • Support supplier regulatory documentation, including declarations, certificates, compliance forms, and supplier change notifications.
  • Help ensure product documentation is complete, accurate, controlled, and audit-ready.
Job responsibilities within our organization are dynamic.  This may not be a complete list of duties.  Other responsibilities and duties may be assigned by your supervisor or upper management.
Education & Experience
  • Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or related technical discipline.
  • Minimum 8-10 years of experience in Regulatory Affairs, Quality Assurance, or Compliance within a medical device environment.
  • Hands-on experience with Class I medical devices required.
  • Working knowledge of FDA 21 CFR Part 820, ISO 13485, and medical device documentation requirements.
  • Experience supporting technical documentation, DHF/DMR files, change control, labeling review, and audit preparation.
  • Strong attention to detail and ability to manage documentation in a controlled QMS environment.
  • Ability to work cross-functionally with Engineering, Quality, Operations, and external customers.
  • Strong written and verbal communication skills.
  • Ability to organize regulatory information clearly and respond to customer or auditor requests in a professional manner.
  • Experience with Class II medical devices strongly preferred.
  • Experience supporting 510(k), FDA submissions, EU MDR technical files, or international registrations preferred.
  • Familiarity with IEC 60601-1, IEC 62304, IEC 62366, ISO 14971, and electrical medical device requirements preferred.
  • Experience in a contract manufacturing or complex electromechanical manufacturing environment preferred.
  • Experience with customer audits from large medical device OEMs preferred.
  • Experience with QT9, NetSuite, Master Control, Greenlight Guru, Arena, or similar eQMS/ERP systems preferred.
  • RAC certification or regulatory affairs coursework preferred but not required.
Skills & Abilities
  • Excellent organizational skills and strong attention to detail.
  • Proactive and capable of managing multiple priorities while adapting to changing business needs.
  • Effective communication and collaboration skills across departments.
  • Comfortable working in a fast-paced, cross-functional team environment, working extended hours (as needed).
  • Strong self-motivation and attitude for personal career growth, willingness to self-learn, and work in new technology domains
  • Proficient in Microsoft Excel and working knowledge of Microsoft Office Suite.
Physical Job Requirements
The employee in the position will be required to occasionally move throughout the facilities, including climbing stairs, when necessary.  Occasional bending and reaching in an office environment, including opening and closing file cabinets drawers with light grasping. Type on a standard keyboard (laptop or desktop). Use standard computer display screens.  Use standard push-button phones and must speak clearly and be understood by others.  Sit or stand in a standard upright position for a minimum of one hour, but up to 12 hours a day. Be able to lift and carry weight unassisted not exceeding 50 lbs.
Compensation and Benefits
  • Salary Range: $120k - $150k (based on experience and qualifications)
  • Medical, vision and dental insurance
  • 401(k) with company match (100% of the first 4% in eligible compensation)
  • Flexible Spending Account
  • 2 weeks paid vacation
  • 1 Week sick pay
  • 10 company holidays
  • Group life insurance

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