ISO 13485:2016 Medical Device Lead Assessor
3 weeks ago
iso medical device lead assessor ISO 13485:2016 Medical Device Lead Assessor Are you an experienced auditor with a passion for quality in the medical device industry? Join our team as an ISO 13485:2016 Lead Assessor at JC Auditors, a leading conformity assessment body with a client-focused approach to promoting medical device performance and efficacy. Employment Type: Freelance Contract Industry: Medical Devices | Quality Assurance | Regulatory Compliance Experience: Minimum 5 years Travel: Extensive What You'll Do: Conduct ISO 13485:2016 audits for medical device manufacturers and suppliers Assess compliance with regulatory and quality requirements (SAHPRA) Provide expert guidance on risk management, QMS implementation, and continual improvement Work with a dynamic team committed to upholding the highest industry standards What We’re Looking For : BSc Degree in one or more health science professional areas (biomedical science, medical science, microbiology, chemistry, biochemistry, bioengineering, human physiology, pharmacy, physics) Certified Lead Auditor for ISO 13485:2016 (IRCA registered course preferred) Minimum of 5 years work experience in the medical device industry Proven experience in auditing medical device organizations and conducting 3 rd party- audits Current Audit Log reflecting all completed audits and technical areas Strong experience in medical devices, SAHPRA regulatory compliance and quality assurance Knowledge of related standards (ISO 14971, ISO 9001) and global regulatory frameworks Knowledge of MD5, MD9 and ISO 17021 Ability to travel Excellent communication and stakeholder engagement skills Excellent analytical, writing and reporting skills Why Join Us? Work with a globally recognized conformity assessment body Opportunity to make an impact in the medical device industry Professional growth and continuous learning #J-18808-Ljbffr
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Medical Devices Qms Iso13485 Auditor(Remote)
4 weeks ago
WorkFromHome, South Africa Bsi Full timeWe exist to create positive change for people and the planet. Join us and make a difference too! Position Medical devices QMS auditor Location South Korea (home based) What duties you'll perform As a RS Client Manager (Assessor) you'll be responsible for frequently travelling and having overnight stays across the South Korea. You'll assess ISO quality...
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Remote Medical Devices QMS Auditor — ISO13485
4 weeks ago
WorkFromHome, South Africa Bsi Full timeA leading standards organization is seeking a Medical devices QMS auditor to perform audits and assessments in the South Korea region. You will be responsible for conducting evaluations according to ISO standards and medical device regulations, preparing reports, and leading assessment teams. The role requires a Bachelor's degree and at least 5 years of...
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WorkFromHome, South Africa BSI Full timeWe exist to create positive change for people and the planet. Join us and make a difference too! Job title: Technical Specialist and Scheme Manager (Microbiology)-relocation acceptable Location: Japan/South Korea (remote) This role required to work in Japan or South Korea Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an...
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Iso 13485 Lead Auditor – Remote Contract
2 weeks ago
WorkFromHome, South Africa Imsm Full timeResponsibilities A consultancy firm specializing in ISO standards is seeking a Lead Auditor for ISO. This role involves conducting audits, delivering consultancy, and providing actionable recommendations while engaging with clients in a flexible, hybrid environment across South Africa. Qualifications The ideal candidate must possess an IRCA certification and...
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WorkFromHome, South Africa Asclepion Laser Technologies GmbH Full timeA leading international medical device company seeks a Freelance Business Development Expert for the Middle East/Africa. The role focuses on building a distribution network, leading marketing initiatives, and managing key accounts. Candidates should have proven experience in medical device sales, strong networking abilities, and excellent communication...
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Global Export Sales Manager — Medical Devices
2 weeks ago
WorkFromHome, South Africa Smith & Nephew Full timeA global medical technology company is seeking an Export Sales Manager in Johannesburg. The role involves leading and optimizing the international distributor network to drive strategic growth. Candidates should have a Bachelor’s degree in Business Administration or International Business, with 5–8 years of experience in medical devices and strong skills...
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Global Export Sales Leader – Medical Devices
1 week ago
WorkFromHome, South Africa Smith & Nephew Full timeA leading medical technology company is seeking an Export Sales Manager to lead and optimise their international distributor network. The role requires strong communication skills and experience in international trade, ideally within the medical devices sector. Candidates should have a Bachelor's degree and 5–8 years of relevant experience. The position...
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Hybrid Global Export Growth Leader
2 weeks ago
WorkFromHome, South Africa Smith & Nephew Full timeA leading medical technology company is seeking an Export Sales Manager in Gauteng, South Africa. This role will lead the international distributor network with a focus on strategic growth and operational excellence. The ideal candidate should have a bachelor's degree, 5–8 years of experience in medical devices, and strong skills in international trade,...
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WorkFromHome, South Africa Sapics Full timelead auditors iso 9001 iso 45001 iso 14001 iso 22000 Lead Auditors for ISO 9001, ISO 45001, ISO 14001, ISO 22000 Are you an experienced auditor who understands how to apply risk based audits in a highly relational and contextual manner? Join our team as a contract lead auditor at JC Auditors, a leading conformity assessment body with a client-focused...
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WorkFromHome, South Africa BSI Full timeWe exist to create positive change for people and the planet. Join us and make a difference too! Job Title Technical Specialist- IVD (In Vitro Diagnostic) Location South Korea BSI is seeking R&D Scientists and Production Scientists to join our IVD Devices Team as a Technical Specialist and Scheme Manager for CE Marking clients. Specifically we are seeking...
