Director of Manufacturing & Regulatory Affairs

Lavior Pharma Inc

About The Position

The Director of Manufacturing & Regulatory Affairs will lead and scale Lavior’s manufacturing and regulatory operations in close collaboration with our US-based ISO 13485-certified contract manufacturer. This executive-level role is responsible for: Ensuring full ISO 13485 quality system compliance Optimizing manufacturing efficiency and scalability Overseeing supplier qualification and global sourcing (including China and Mexico) Leading Class I, II, and III regulatory submissions Building a robust, audit-ready operational infrastructure to support international expansion This is a hands-on leadership role suited for an experienced operator who has successfully worked in growing companies and understands how to scale manufacturing within regulated medical device environments. The Director will report directly to the CEO and play a critical role in supporting Lavior’s global growth strategy.

Requirements

8–15+ years of experience in medical device or regulated skincare manufacturing
Strong hands-on experience with ISO 13485-certified contract manufacturers
Demonstrated experience scaling operations in a growing company environment
Direct involvement in regulatory submissions (Class I–III preferred)
Experience managing US-based manufacturing partnerships
Deep knowledge of production planning and manufacturing process optimization
Strong understanding of Quality Control systems and regulatory compliance
Experience implementing and improving QMS frameworks
Familiarity with pharmaceutical-grade or wound care manufacturing processes
Proven ability to lead cross-functional initiatives
Strong operational and strategic thinking capabilities
Excellent problem-solving skills and attention to detail
Ability to build systems and processes in a scaling organization
Comfortable working in a fast-paced, high-growth environment
Bachelor’s degree in Biomedical, Chemical, Industrial, or Mechanical Engineering OR Pharmaceutical Sciences / Life Sciences

Nice To Haves

Advanced degree (MBA or Engineering Master’s) is a strong advantage
ISO 13485 Lead Auditor or Regulatory certification is a plus

Responsibilities

Serve as primary operational lead with US-based contract manufacturer
Oversee production planning, validation, and batch consistency
Implement KPIs for quality, efficiency, and cost control
Lead scale-up initiatives and process optimization efforts
Ensure manufacturing documentation and traceability systems are robust and audit-ready
Maintain and improve the Quality Management System (QMS)
Develop and refine SOPs, CAPA, change control, and risk management processes (ISO 14971)
Prepare for and support regulatory audits and inspections
Ensure adherence to FDA and international regulatory standards
Lead preparation and submission of Class I, II, and III medical device registrations
Maintain technical documentation and regulatory files
Ensure labeling, claims, and product documentation compliance
Support regulatory strategy for new international markets
Identify, evaluate, and qualify global suppliers for bottles, packaging, and components
Conduct supplier audits and establish quality agreements
Balance cost optimization with compliance and quality standards