Senior Principal Regulatory Affairs Specialist - Transfusion

• Coordinates preparation, review and submission of product applications (510(k), BLA, Medical Device Licence Applications/Amendments, and Technical Documentation
• Prepares and maintains Technical Files (Technical Documentation)
• Reviews and approves quality system documents to determine compliance with SOPs, quality system and regulatory compliance, and industry standards
• Reviews and approves significant changes (e.g. facility, product, process and labeling changes) for regulatory impact and domestic and international reporting requirements
• Maintain regulatory product files of information submitted in support of domestic and international registrations
• Coordinates field action and vigilance activities for Werfen product lines and notifies appropriate regulatory agencies, affiliates and distributors
• Performs tasks and functions associated with product recalls/field corrections including preparing customer notifications, government submissions, status reports and recall effectiveness checks
• Evaluates complaint and internal deviation report data to determine the need for Medical Device Reporting, field action or Biological Product Deviation reporting
• Maintains compliance with Medical Device Listing requirements for Werfen products
• Recognizes and elevates critical regulatory/compliance issues to RA management
• Assists with the administration of regulatory and third-party inspections
• Performs other duties as assigned

• Bachelor’s degree (BS/BA) from four-year college or university
• or equivalent combination of education and experience
• RAC certification, preferred
• Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, and government regulations
• Ability to write reports, business correspondence and procedure manuals
• Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference and volume
• Ability to apply concepts of basic algebra and geometry
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exist
• Ability to interpret a variety of instructions furnished in written, oral, diagram, and schedule form

RAC certification