Audit and Compliance Manager

Role: Audit and Compliance Manager

Location:  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:
o       MDSAP Audit Model
o       ISO 13485:2016
o       Applicable regulatory requirements of:
§       FDA (21 CFR 820)
§       Health Canada
§       TGA (Australia)
§       PMDA/MHLW (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