Goldenpath Process Management

Project-Based ISO 22716 & ISO 13485 Consultants / Documentation Specialists

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: TYPE OF WORK

Gig

: WAGE / SALARY

TBD

: HOURS PER WEEK

TBD

: DATE UPDATED

May 28, 2026

JOB OVERVIEW

We are looking for experienced project-based ISO Consultants / Documentation Specialists to support two separate ISO implementation and certification preparation projects.

We are hiring for the following roles:
• 1 ISO 22716 Consultant / Cosmetics GMP Documentation Specialist
• 1 ISO 13485 Consultant / Medical Device QMS Documentation Specialist

Applicants may apply for one role or both, depending on their actual hands-on experience.

These are project-based remote engagements focused on end-to-end implementation preparation, documentation development, client meetings, awareness briefings, internal audit support, corrective actions, and certification readiness.

Applicants with a relevant ISO portfolio or redacted sample work will be prioritised.

Responsibilities:
• Build ISO documentation from scratch based on the applicable standard
• Prepare procedures, manuals, forms, checklists, work instructions, records, and related implementation documents
• Conduct gap assessments and identify missing compliance requirements
• Meet with clients to discuss requirements, implementation progress, and required actions
• Provide ISO awareness briefings or basic training to client teams
• Set up document control and records management procedures
• Conduct or support internal audits based on the applicable ISO standard
• Prepare audit reports, corrective action plans, and certification readiness documents
• Support the client through the end-to-end implementation process until certification readiness

Required Experience:
For the ISO 22716 role, applicants must have hands-on experience in:
• ISO 22716 / Cosmetics GMP implementation
• Cosmetics, skincare, personal care, manufacturing, quality assurance, or related compliance work
• GMP documentation, internal audit, awareness briefing, and certification preparation

For the ISO 13485 role, applicants must have hands-on experience in:
• ISO 13485 / Medical Device QMS implementation
• Medical devices, diagnostics, healthcare products, manufacturing, distribution, quality assurance, regulatory affairs, or related compliance work
• QMS documentation, internal audit, awareness briefing, and certification preparation

Qualifications:
• Relevant certificates of training for the applicable ISO standard
• Experience creating ISO/GMP/QMS documents from scratch
• Experience conducting or supporting internal audits and preparing audit reports
• Able to independently facilitate client meetings and explain ISO requirements clearly
• Strong written communication skills
• Reliable, organised, and able to meet project deadlines
• Can work independently and manage project deliverables with minimal supervision

Preferred:
• Internal Auditor or Lead Auditor training for ISO 22716, ISO 13485, or related standards
• Experience helping companies prepare for external certification audits
• Other ISO standards, compliance areas, or related qualifications

Project Details:
• Engagement type: Project-based
• Work setup: Remote
• Number of roles: 2 separate consultants
• Role 1: ISO 22716 / Cosmetics GMP
• Role 2: ISO 13485 / Medical Device QMS
• Duration: Until completion of implementation preparation and certification readiness
• Meetings: Must be available to attend client meetings during UK business hours when required
• Payment: Project rate or milestone-based, to be discussed

To apply, please complete our application form here: ----------

Please prepare the following before completing the form:
• Updated CV or resume
• Certificates and training records for the applicable ISO standard
• Summary of your ISO 22716 and/or ISO 13485 implementation experience
• Other ISO standards, compliance areas, or related qualifications you have experience or training in
• Portfolio or redacted samples of previous ISO-related work
• Current availability and existing work commitments
• Expected project rate, milestone rate, or consulting fee

Note: Priority will be given to applicants who can provide a relevant portfolio or redacted samples of previous ISO documentation, GMP/QMS procedures, audit reports, training materials, implementation plans, risk management documents, or certification readiness work.

Applicants with strong hands-on ISO 22716 or ISO 13485 implementation experience will be prioritised.

SKILL REQUIREMENT

Documentation Regulatory Compliance

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Goldenpath Process Management

Project-Based ISO 22716 & ISO 13485 Consultants / Documentation Specialists

Please login or register as jobseeker to apply for this job.

TYPE OF WORK

WAGE / SALARY

HOURS PER WEEK

DATE UPDATED

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