Is Medical Device ISO13485 auditor/ assessor(homebased) at BSI Group a remote job?

Yes. Medical Device ISO13485 auditor/ assessor(homebased) at BSI Group is a fully remote role open to candidates worldwide.

Click the "Apply" button on this page to go to the official application at BSI Group.

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BSI Group

Medical Device ISO13485 auditor/ assessor(homebased)

Assess medical device manufacturers' ISO 13485 quality systems across APAC

As a Medical Device Auditor, you will travel to medical device manufacturers across APAC to assess their ISO 13485 quality management systems. Your evaluations will help manufacturers improve performance, ensure patient safety, and comply with regulatory procedures. The role is home-based with required travel across the APAC region.

Why This Role?

Help medical device manufacturers improve performance and ensure patient safety

Key Responsibilities

Travel to medical device manufacturers across APAC for on-site assessments
Assess ISO 13485 quality management systems of medical device manufacturers
Evaluate compliance with regulatory procedures and quality standards
Provide feedback to help manufacturers improve their quality management performance
Document audit findings and prepare assessment reports
Support manufacturers in achieving and maintaining ISO 13485 certification

Requirements

Experience in medical device quality management systems
Knowledge of ISO 13485 standard and its application
Background in auditing or assessing quality management systems
Ability to travel across the APAC region for on-site assessments
Understanding of regulatory requirements for medical devices
Strong communication and reporting skills for audit feedback

Required Skills

auditingquality-managementregulatory-compliancemedical-devicesISO 13485 auditingMedical device quality systemsRegulatory compliance assessmentAPAC market knowledgeAudit reportingStakeholder communication

Indonesia Context

Working Hours Overlap:: Flexible — work your own hours

See remote (USD) vs local pay →

View Original Description from Adzuna

Original description from Adzuna

We exist to create positive change for people and the planet. Join us and make a difference too! Medical Device Assessor Singapore – homebased, travel required ,local hire As a Medical Device Auditor, you’ll travel to medical device manufacturers across APAC. You’ll help these manufacturers to improve their performance by assessing their ISO 13485 quality management system, so they can ensure patient safety and comply with regulatory procedures. In the first six months of being a Medical Device…

Salary Context

Similar Legal & Compliance roles on LokerDollar pay around $134.1k/yr (range $51k–384k/yr, n=8 active listings).

Openness not stated by employer — check the listing

Company

BSI Group

Source

Adzuna

Job Type

full time

Location

Remote · Open worldwide

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Frequently asked questions

Is Medical Device ISO13485 auditor/ assessor(homebased) at BSI Group a remote job?: Yes. Medical Device ISO13485 auditor/ assessor(homebased) at BSI Group is a fully remote role open to candidates worldwide.
What type of employment is Medical Device ISO13485 auditor/ assessor(homebased) at BSI Group?: This is a full time position.
How do I apply?: Click the "Apply" button on this page to go to the official application at BSI Group.

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