OX Biomed
Director of Quality & Regulatory Compliance
Reno, NV · Director
Sponsorship not specifiedDetected 20 days ago
ComplianceAuditingSupply ChainLogisticsProcess ImprovementPatient CareFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem SolvingInternal AuditRegulatory Affairs
About the role
- This leadership role is critical in safeguarding product integrity, ensuring regulatory compliance, and protecting patient safety, while supporting organizational growth and operational excellence.
Responsibilities
- Monitor regulatory changes and proactively update company policies, procedures, and SOPs to maintain compliance and industry best practices.
- Prepare for, lead, and represent the organization during regulatory inspections, third-party audits, and accreditation assessments.
- Manage regulatory submissions, facility registrations, and state tissue bank licenses; ensure timely renewals and filings.
- Lead development, implementation, and maintenance of a robust QMS aligned with cGTPs and AATB standards.
- Oversee document control, change management, CAPA, deviation investigations, complaint handling, and continuous improvement initiatives.
- Approve and maintain SOPs, policies, controlled documents, and training records to ensure operational compliance.
- Lead internal audit programs and management reviews to ensure QMS effectiveness. Product Release & Traceability
- Develop and maintain compliance-focused training programs across the organization.
- Lead and mentor the Quality & Regulatory Compliance team; build organizational capability and succession planning.
- Partner cross-functionally with Supply Chain, Operations, Clinical Affairs, R&D, and Commercial functions to ensure alignment and quality oversight.
Nice to have
- Preferred Certifications
- Certified Quality Auditor (CQA), Certified Quality Manager (CQM), or RAC certification.
- AATB CTBS (Certified Tissue Bank Specialist) strongly preferred.
- Additional quality/regulatory certifications (e.g., Six Sigma, ASQ certifications) a plus.
Benefits
- OX BioMed is a private medical distribution company focused on wound care.
- Training & Education
Company info
- Founded by industry experts, we are driven by patient care and committed to delivering the highest quality products and support.
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This listing is sourced directly from OX Biomed's careers page and normalized into a canonical job model.