Director, Regulatory Compliance/Quality Systems
Quality, Regulatory, Operations
BD (Becton, Dickinson and Company)
The Director, Regulatory Compliance/Quality Systems position is responsible for: developing, assuring that the organizational structure, responsibilities, procedures, processes, and resources for the business Quality Systems and implementation of Quality compliance are adequate to meet the needs of the WW business and conform to all applicable regulatory requirements, including all adopted industry standards and BD Corporate Quality and Regulatory Compliance Policies.
Responsible for the development, implementation, and improvement of an effective quality system that meets appropriate WW Business, Division, Corporate, Government, and International Standards for efficacy, safety, quality, and customer satisfaction. Assures programs are consistent and in compliance with FDA Quality System and Pharma type regulations, ISO 13485 and ISO 9000 (and similar) standards for IVD, Medical Device, and Pharma type products in clinical, industrial and research applications as well as custom products designed for specific customers.
Education & Experience
• Requires a bachelor's degree in a scientific or engineering discipline. Individuals with an advanced degree preferred.
• A minimum of 9 years experience in Quality, Regulatory, or Operations of a Medical Device, IVD, Pharmaceutical or Biotech firm.
• A minimum of 3 years directly managing Quality professionals.
• Professional certification is preferred (i.e., RAC, CQA, CAE, SQE, CQM, Six Sigma, etc.)
About BD (Becton, Dickinson and Company)
BD, a leading global medical technology company that makes and sells medical devices, instrumented systems and reagents, is dedicated to improving people’s health throughout the world. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs more than 25,000 people in approximately 50 countries throughout the world.