Austin TX
Job Description:
>> Conduct regulatory audits under the Medical Device Single Audit Program (MDSAP) across multiple jurisdictions.
>> 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.
Requirements:
>> Experience in medical device quality systems and regulatory compliance
>> Certified MDSAP Auditor
>> Knowledge of ISO 13485:2016 and applicable regulatory requirements of FDA, Health Canada, TGA, PMDAMHLW, and ANVISA
>> Ability to conduct MDSAP audits in accordance with the MDSAP Audit Model