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Director, Quality Assurance and Regulatory Affairs

Location: San Diego Salary: bonus, stock options
Sector: Quality Assurance, Regulatory Affairs Type: Permanent

Responsibilities

  • Responsible for building and driving a Quality vision and strategic objectives that aligns with our global operations.
  • Leads and develops strong quality leaders, establishing and actively managing performance expectations, and providing development and training opportunities.
  • Drive projects and improvements/standardization across the company to improve our Quality management system.
  • Ensure global training is effective and that the sites operate within the required regulatory guidelines.
  • Influence and build strong working relationships across organizations and geographies and engage with business partners to define existing gaps and future requirements for Quality Management Systems.
  • Ensure effective management of the Quality Management System including assuring effective management reviews, complaint handling, on-market surveillance, CAPA system, change control, process validation, internal auditing, R&D transfers, and manufacturing support.
  • Drive the continuous improvement of Quality Management Systems at sites around the world, including assuring effective management reviews, complaint handling, CAPA system, change control, internal auditing, R&D transfers, validation, and manufacturing support.
  • Responsible for managing, and executing the regulatory strategies and programs, providing strategic direction and definition to maintain continuous improvement initiatives that will ensure compliance with all current industry standards and regulatory agency requirements for near-term US-FDA approval of its products (and other global IVD regulating agencies).
  • Establishes and implements regulatory strategies and policies for the successful approval of all 510(k) or PMA submissions to the FDA, as well as worldwide, such as CE-IVD (although specific global expertise may be derived from regional consultants).
  • Support the commercialization of New Product Introductions by working with Core Team members.

Experience

  • Bachelor's degree in a Life Sciences field with at least 10 years of Quality experience within the Medical Device, Pharmaceutical Industry or Life Science industry.
  • Experience with Diagnostics/IVD's is strongly preferred.
  • Demonstrated experience working with external customers and commercial teams creating strategies that address customer needs and product specification.
  • Previous experience working global teams.
  • Previous experience supporting New Product Introductions preferred.

Sthree US is acting as an Employment Agency in relation to this vacancy.