Job Details

  • Title: Regulatory Affairs Project Leader
  • Code: RCI-24304
  • Location: Santa Clara, CA 95054
  • Posted Date: 06/23/2022
  • Duration: 12 Months
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  Job Description

Location: Santa Clara, California 

Onsite - open to Hybrid 4 days onsite and day remote
  • 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.
Top skills: (Any skills is fine but submission is great to have) 

  • 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)