Job Title : MDSAP Auditor Medical Device Single Audit Program
Location : Austin, TX
Type : Contract
SKILL
Internal Auditing
AI SUG KEY SKILLS
MDSAP ISO 13485 Regulatory Compliance Quality Management Auditing
AI SUG INTERVIEW QUESTIONS
What experience do you have with MDSAP audits? Can you explain the importance of ISO 13485 in medical device auditing? How do you stay updated with global regulatory changes? Describe a challenging audit you conducted and how you handled it? What methods do you use to communicate audit findings to clients?
ADDN NOTES
JOB DESCRIPTION
We are seeking an experienced MDSAP Auditor to conduct regulatory audits under the Medical Device Single Audit Program (MDSAP) across multiple jurisdictions. The ideal candidate will be a certified auditor with extensive experience in medical device quality systems, regulatory compliance, and auditing against global regulatory requirements including FDA, Health Canada, TGA, PMDA, and ANVISA. Key Responsibilities Plan, conduct, and lead MDSAP audits in accordance with: o MDSAP Audit Model o ISO 13485:2016 o Applicable regulatory requirements of: FDA (21 CFR 820) Health Canada TGA (Australia) PMDAMHLW (Japan) ANVISA (Brazil) Evaluate medical device manufacturers Quality Management Systems (QMS), including: o Risk Management o Design and Development o Production and Process Controls o CAPA o Complaint Handling and PMS Assess compliance across audit tasks such as: o Management Responsibility o Measurement, Analysis, and Improvement o Device Marketing Authorization and Facility Registration Prepare comprehensive audit reports, findings, and nonconformance classifications Communicate audit results clearly to clients and regulatory stakeholders Support follow-up activities, including CAPA review and closure Maintain auditor competence and adhere to accreditation body requirements Stay current with global regulatory updates, guidance, and MDSAP changes
Thanks and Regards,
Saint Singh
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