Job Title: Regulatory Affairs Consultant
* Create and update European Technical File, Declaration of Conformity, and classification documents according to the new European Medical Device Regulations (EU MDR). Communicate identified gaps, track status through closure and work with the project team on update activities.
* Review and approve product labeling plans, labeling, and marketing communications
* Support EUDAMED database data collection and uploads
* Support QMS system updates for compliance with the EU MDR
* Support internal and external quality audits, as needed.
* Provide regulatory training and guidance to assigned medical device new product development and sustaining projects as it relates to EU MDR.
* Knowledge on QMS systems and EUDAMED database
* Processing Expense reporting on behalf of management team
* Running reports through Business Objects system
* Take meeting minutes and distributing to meeting attendees
* ShareFolder cleanup and redevelopment, developing work related 'cheat sheets' for the team, updating guideline spreadsheets with information
* Assist Management team with administrative ad hoc projects; Publishing Submissions,
Copying, Scanning, Printing, Compiling Documentation, audit preparations, etc.
* Process Invoicing and Fees via PO Request/Purchase Requisitions
* A strong ability to audit and find errors in documentation and trackers
* Ability to evolve based on team needs for administrative functions
* High attention to detail, highly skilled in task management, task oriented
* Ability to solve problems and provide solutions
* Flexible with priorities and responsibilities
* Works well under pressure in a dynamic and social environment
* Effective organizational skills
* Strong work ethic
* Works well under pressure in a dynamic environment
* General knowledge of industry practices, techniques and standards
* Intermediate/Advance knowledge of word processing, spreadsheet/graphing, including knowledge of Microsoft Office applications, including Word, PowerPoint.
* SAP experience
* Expert level Excel