Regulatory Affairs Specialist, Class III and II Medical Devices
Location: Dallas TX
Our client is a pioneering leader in MR-guided, noninvasive treatment solutions in neurosurgery among other clinical areas. This is an exceptional opportunity to join this exceptional company. The position is office based in DFW area.
1) A minimum of 5 years of Regulatory Affairs experience with US FDA Class III and/or Class II medical devices
2) B.S. or B.A. degree in a scientific or technical discipline. Advanced degree preferred.
3) A minimum of 8 years of working in an FDA regulated environment.
4) Must have experience with regulatory registrations and submissions in markets such as the US and Canada
5) RAPS RAC (US) preferred
Preparation and maintenance of regulatory submissions and registrations of devices in the US (FDA) and Canada (Health Canada)
Preparation and submittal of periodic reports for Class III devices in the US
Preparation and maintenance annual renewals of Establishment Registrations, Device Listing, and other pertinent regulatory licenses
Review of customer complaints to determine regulatory reportability requirements; In collaboration with the RA Director, preparation/submittal of regulatory reportable events
Actively participate in evaluation of changes to the QMS documents and device design/process for impact on pending or existing registrations
Review complex reports, validations, etc. for scientific merit and regulatory appropriateness;
Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
In collaboration with the RA Director, advise project teams on premarket regulatory requirements, labeling requirements and/or clinical study compliance issues
Monitor and advise the RA Director of upcoming or new guidance, regulations, agency/industry initiatives, etc. to ensure regulatory strategies are in alignment with company objectives
Interpretation of regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures
Participate in compliance activities that relate to the department and the company, when needed
Work closely with various teams (i.e. Regulatory Affairs, R&D, Quality, Manufacturing and Marketing) located at HQ and ROW
Apply business and RA ethical standards
Perform due diligence; Assess and interpret regulatory requirements and their impact
Work with cross-functional international teams