OX BioMed · 1 day ago
Director of Quality & Regulatory Compliance
Reno, NV
Contract
Onsite
Director/Executive
7+ years expOX BioMed is a private medical distribution company focused on wound care, dedicated to delivering high-quality products and support. The Director of Quality and Regulatory Compliance is responsible for establishing and managing a comprehensive quality system and regulatory strategy to ensure compliance with FDA regulations and industry standards, while safeguarding product integrity and patient safety.
Hospital & Health Care
Responsibilities
Ensure organizational compliance with FDA 21 CFR Part 1271, cGTPs, AATB standards, and all applicable federal, state, and local requirements
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
Oversee audit responses, corrective actions, and risk mitigation activities
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
Establish metrics and KPIs to monitor quality performance and compliance trends
Lead internal audit programs and management reviews to ensure QMS effectiveness
Oversee product release processes, ensuring documentation meets quality and regulatory requirements
Ensure robust traceability systems are in place to track HCT/Ps from donor receipt through processing, storage, and distribution
Monitor labeling, packaging, storage, and distribution practices to ensure product integrity and regulatory compliance
Partner with supply chain and logistics teams to ensure compliant handling and transportation
Develop and maintain compliance-focused training programs across the organization
Ensure personnel competency in SOPs, quality requirements, and applicable regulations
Conduct periodic compliance training and oversee training record management
Lead and mentor the Quality & Regulatory Compliance team; build organizational capability and succession planning
Provide strategic guidance to senior leadership on compliance risks, trends, and mitigation strategies
Partner cross-functionally with Supply Chain, Operations, Clinical Affairs, R&D, and Commercial functions to ensure alignment and quality oversight
Serve as the primary contact with regulatory bodies, accreditation agencies, contract manufacturers, and tissue bank partners
Qualification
Required
Bachelor's degree in Life Sciences, Regulatory Affairs, Quality Assurance, Biomedical Engineering or related field; Master's degree preferred
Minimum of 7–10 years of progressive experience in quality and regulatory roles within the biologics, tissue banking, HCT/P, or medical device industry
In-depth knowledge of FDA 21 CFR Part 1271, cGTPs, and AATB standards
Demonstrated experience preparing for and leading FDA inspections, AATB accreditations, and third-party audits
Strong expertise in QMS development, implementation, and electronic documentation systems
Excellent analytical, communication, leadership, and problem-solving skills
Preferred
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
Company
OX BioMed
Ox BioMed is a systems-first wound care partner built to simplify complexity and protect providers.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase