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    • Execute manual certification testing on physical supplier devices using ITSO tooling and test environments.
    • The Test Analyst – Certification is responsible for…
    • Experience in both medical device and pharmaceutical quality environments, especiallycombination products.
    • Working knowledge of combination product regulations,…
    • Previous experience working within a quality environment in the Food, Consumer, Pharmaceutical or Medical device industry.
    • Domain: Class III medical device · regulatory compliance and lifecycle management.
    • Supporting regulatory strategy and compliance planning for Class III medical…
    • Potential to develop specialist expertise in medical device regulation.
    • Managing regulatory submissions and maintaining compliance documentation for Class III…
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    • Supporting preparation and submission of regulatory documentation for medical device applications.
    • Previous experience in a medical device or regulated life…
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    • Proven experience in Regulatory Affairs within the medical device industry.
    • Experience with Class I and Class IIa medical devices or higher.
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    • Proven experience in regulatory affairs or medical device compliance.
    • Domain: Class III medical device · regulatory and compliance affairs.
    • How many years of experience do you have of Product Management & Marketing within the medical device industry?
    • Competitive salary with bonus scheme.
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    • Developing and maintaining regulatory strategy for medical device portfolios.
    • Exposure to cutting-edge medical device development and regulatory pathways.
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    • Understanding of Class III medical device regulatory pathways and approval processes.
    • Supporting the preparation and submission of regulatory documentation for…
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    • Domain: Class III medical device · ISO 13485 · IEC 62304.
    • Working knowledge of ISO 13485, IEC 62304 and Class III medical device validation.
    • Experience within Regulatory Affairs, Quality, or another regulated medical device environment.
    • Understanding of medical device regulatory submissions,…
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    • Experience with Class III medical device programmes or comparable regulated environments.
    • Exposure to Class III medical device development from design through…
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    • Domain: Class III medical device · validation and compliance.
    • Demonstrated experience with ISO 13485 and IEC 62304 in a medical device or comparable regulated…

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Job Post Details

Test Analyst - Certification (office based) - job post

ITSO Ltd
Milton Keynes
£35,000 - £45,000 a year - Permanent, Full-time

Job details

Pay

  • £35,000 - £45,000 a year

Job type

  • Permanent
  • Full-time

Location

Milton Keynes

Benefits

Pulled from the full job description

  • Referral programme
  • Sick pay
  • Life insurance
  • Private dental insurance
  • Company pension
  • Discounted or free food
  • Private medical insurance

Full job description

Job Overview

The Test Analyst – Certification is responsible for delivering supplier certification activities against the ITSO Specification. The role ensures that supplier products and solutions are manually tested consistently, accurately and in accordance with the ITSO Certification Scheme.

The role supports suppliers throughout the certification process by developing certification test plans, conducting hands-on compliance testing of physical supplier devices using ITSO test tooling and environments, and producing certification evidence and reports.

The Test Analyst acts as a technical specialist for supplier assurance activities and contributes to the continual improvement of ITSO certification services and test artefacts.

Role Focus

Primary focus: Conduct hands-on supplier certification testing of physical devices, including certification planning, compliance testing, certification evidence and reporting.

Secondary capability: Support internal product testing, regression activities and test automation initiatives where required.

Key Responsibilities

Supplier Certification

  • Deliver certification activities for supplier products and solutions.
  • Review supplier applications and certification scopes.
  • Develop certification test plans based on supplier implementations.
  • Map supplier functionality against mandatory and optional ITSO requirements.
  • Execute manual certification testing on physical supplier devices using ITSO tooling and test environments.
  • Produce certification reports and supporting evidence.
  • Support certification recommendation activities.

Certification Testing

Perform certification testing across:

  • HOPS.
  • POST.
  • PersoPOST.
  • ISAM.
  • Media.
  • Future ITSO certified products and services.

Responsibilities include:

  • Compliance testing.
  • Functional testing.
  • Regression testing.
  • Interoperability testing.
  • Specification conformance testing.

Test Artefact Management

  • Maintain certification test scripts and test cases.
  • Maintain reusable test data sets and card profiles.
  • Maintain regression packs for common product types.
  • Maintain traceability between certification tests and specification requirements.
  • Support updates resulting from specification changes and Technical Notes.

Supplier Support

  • Provide technical clarification during certification activities.
  • Support supplier onboarding sessions.
  • Assist suppliers in understanding certification requirements.
  • Support issue resolution during testing.
  • Participate in certification review meetings where required.

Continuous Improvement

  • Identify opportunities to improve certification processes and test artefacts.
  • Support automation initiatives where appropriate.
  • Contribute to certification guidance and documentation.
  • Provide feedback on specification and certification improvements.

Key Outputs

  • Certification test plans.
  • Certification reports.
  • Certification evidence packs.
  • Certification test scripts.
  • Regression test packs.
  • Test data sets and card profiles.
  • Supplier technical feedback.

Measures of Success

  • Certification activities delivered to agreed timescales.
  • High-quality and repeatable certification testing.
  • Accurate certification evidence and reporting.
  • Effective supplier engagement throughout certification.
  • Improved certification test coverage.
  • Reduced certification rework and clarification activities.

Skills & Experience

Strong knowledge of:

  • ITSO Specification.
  • Supplier certification processes.
  • Smart ticketing technologies.
  • Test methodologies and defect management.

Experience in:

  • Compliance testing.
  • Functional and regression testing.
  • Supplier-facing technical activities.
  • Producing technical test documentation.

Ability to:

  • Interpret technical specifications.
  • Produce high-quality test artefacts.
  • Communicate technical issues clearly.
  • Work collaboratively with suppliers and internal stakeholders.

Job Types: Full-time, Permanent

Pay: £35,000.00-£45,000.00 per year

Benefits:

  • Casual dress
  • Company pension
  • Discounted or free food
  • Health & wellbeing programme
  • Life insurance
  • On-site parking
  • Private dental insurance
  • Private medical insurance
  • Referral programme
  • Sick pay
  • Transport links

Work Location: In person

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