Job Details

• Need exp in technical submissions. 510K submission, EUMDR is good to see. FDA knowledge is ok 
• Work independently 
• Looking for some experience not right out of school 
• EUmdr and mdr  
• 510K and Canadian, international, pma, medical device is preferred 
• 2 years of experience with submission 
• This position is onsite. 
• Want someone with regulatory affairs exp. 
• Regulatory affair specialist will work 
• Few years of experience needed 
• Regulatory affairs and Submission exp needed 
• Preparation of submission and technical file 
• Any regulatory experience is fine, but submission is great to have 
• Prefer more senior experience on standard regulations and submission experience 
• Don’t need medical experience more international different geography is good 
• Degree – open to see anything with Bachelor level or higher.

• Expert in FDA 
• Writing skills 
• Regulatory experience 
• Submission documentation 
• Expert in submission 

Education:

• Bachelor's degree required, Masters degree preferred

Skills:

• Knowledge of US and/or Canadian regulation relating to product and/or device clearance (FDA)