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Senior Director of Quality Assurance and Regulatory Affairs

2 months ago

Norcross, Georgia, United States Immucor Full time
Job Title: Senior Director, Quality Assurance & Regulatory Affairs

We are seeking a highly experienced and results-driven Senior Director to lead our Quality Assurance and Regulatory Affairs team. As a key member of our leadership team, you will be responsible for ensuring the site Quality Management System is established, implemented, and maintained in accordance with applicable US Federal Regulations, Regulation EU 2017/746, and EN ISO 13485 standards.

Key Responsibilities:
  • Establish and maintain a Quality Management System that meets regulatory requirements.
  • Lead the Quality Assurance, Quality Control, and Regulatory Affairs organization.
  • Interface with top management personnel to set policy and ensure adherence to regulatory standards.
  • Make decisions on product acceptability and release.
  • Organize and manage the Quality and RA organization, including budget, personnel, and training.
Requirements:
  • Bachelor's Degree in Science or Engineering.
  • Minimum 10 years of experience in Quality Assurance and Regulatory Affairs, preferably in the IVD, Medical Device, and/or bio-pharmaceutical industry.
  • Demonstrated track record in successful US FDA, EU, and ROW premarket audits/inspections and regulatory submissions.
  • Ability to establish processes and systems meeting Quality System Regulations (QSR), 21CFR Parts 210, 211, 11, and 820, ISO 13485, and ISO 14971 requirements.
About Us:

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. We operate directly in 30 countries and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.