Our client is a pioneering leader in MR-guided, non-invasive 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.
If you think you have the critical skills below, pls apply today for this open job and we will call you for a confidential discussion. Pls, note there is no relocation assistance for this role.
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
Apply today for immediate consideration!