Job Details

Position can be remote (east coast preferred) or onsite in Atlanta, GA.

• Degree in engineering or scientific background
• Minimum of 3-5 years of Regulatory Affairs submission authoring experience in Class III Active Implantable Medical Devices or Class II Medical Devices
• Experience with EU MDR (Medical Device Regulations) highly preferred; not to be confused with MDR Vigilance Reporting experience (Regulatory Compliance), which is not applicable.
• Other critical soft skills: Excellent communication verbal and written skills
• Ability to lead independently with strong critical analysis skills
• This contract position is for the EU MDR submission project and will dependent on when the EU MDR submission will be finished.
• Need someone onboard quickly, will interview ASAP. Need start up mentality - must be able to fill in gaps for MDR and submissions writing.