Senior Principal Regulatory Affairs Specialist - Transfusion and Transplant

Werfen•Norcross, GA

About The Position

As a Senior Principal Regulatory Affairs Specialist, you will perform regulatory affairs and quality system support activities associated with the manufacture and distribution of the Werfen product lines for U.S., Canada, and European Union.

Requirements

Bachelor’s degree (BS/BA) from four-year college or university; or equivalent combination of education and experience
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 pratical 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

Nice To Haves

RAC certification, preferred

Responsibilities

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