About the Role
We are looking for an experienced Director of Quality and Regulatory Affairs to join our team. The successful candidate will ensure quality systems, processes, specifications, and SOPs are designed to be appropriate for the development, manufacture, testing and timely release, and distribution of quality product, and in compliance with all relevant regulatory requirements including federal, state and international regulations and applicable standards and guidance. The ideal candidate will have experience with orthopedic/spine biologics, excellent communication skills, and the ability to develop creative solutions to customer issues within a regulated environment.
Ensure quality systems, processes, specifications, and SOPs are designed to be appropriate for the development, manufacture, testing and timely release, and distribution of quality product, and in compliance with all relevant regulatory requirements including federal, state and international regulations and applicable standards and guidance.
Provide direction for all QA activities: Quality Systems, Deviations Management, Technology Transfers, Change Management, Quality Control and GMP Facilities.
Ensure all contracted suppliers and manufacturers (internal and external) are operating in compliance with applicable standards and regulations.
Ensure all marketing materials are in compliance with applicable standards and regulations.
Assist in the development of regulatory strategies for our products and assist with preparing regulatory documents for submission to applicable agencies.
Interface with FDA and other regulatory authorities and ensure the company is appropriately represented in matters related to compliance and quality.
Strong knowledge of US and international GTP and GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed product regulatory issues.
Experience: 5 Years Tissue Banking, Medical Device or Biologics (Required)
About the Company
Induce Biologics USA Inc. was founded to develop the next evolution of bone regeneration products. Its founders and management team have previously developed and launched several very successful orthobiologics (bone and tissue repair) products, including several bone graft substitutes.
Induce Biologics is commercializing a family of bioimplants that includes Natural Matrix Protein (NMP™) which replicates the body’s native healing capabilities in order to create natural bone regeneration. The NMP™ proprietary process unlocks the growth factors naturally found in bone, making them bioavailable.
Induce Biologics USA Inc. is a small business in Irvine, CA. We are professional, agile and innovative.
Our work environment includes:
- Modern office setting
- Growth opportunities
Paid time off