Performs a variety of Quality Assurance and international regulatory activities that ensure compliance with FDA, EU and ISO regulatory requirements and reports to the Manager, Regulatory and Clinical Affairs.
· Oversees and manages the Complaint process.
· Facilitates the non-conforming material and Document Control process.
· Coordinates Material Review Board (MRB) disposition with Quality Department, Purchasing, Engineering and Manufacturing as necessary.
· Conducts material movement transactions from and to MRB/NCR (Non-Conformance Report) Inventory on the ERP System.
· Maintains country specific registrations.
· Supports international regulatory product submissions, e-Doc change control system administration.
· Analyzing/trending and reporting of global quality data.
· Provides support to Regulatory Affairs/Notified Bodies/FDA audits.
· Processing regulatory documentation (e.g. notarization, apostilles, legalizations).
· Any other duties, as assigned by Manager, Regulatory and Clinical Affairs.
Experience with filing eMDRs and Vigilance Reports
Proven proficiency using Computer business software; such as, Microsoft Word and Excel (especially for graphing and trending purposes)