Audit and Compliance Manager

Dice is the leading career destination for tech experts at every stage of their careers. Our client, TechClub Inc., is seeking the following. Apply via Dice today!Role: Audit and Compliance ManagerLocation: Austin, TX(100% onsite Role Only)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: MDSAP Audit Model ISO 13485:2016 Applicable regulatory requirements of:FDA (21 CFR 820)Health CanadaTGA (Australia)PMDA/MHLW (Japan)ANVISA (Brazil) Evaluate medical device manufacturers’ Quality Management Systems (QMS), including: Risk Management Design and Development Production and Process Controls CAPA Complaint Handling and PMS Assess compliance across audit tasks such as: Management Responsibility Measurement, Analysis, and Improvement 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