Abbott

Regulatory Affairs Specialist – Vascular

Abbott

full-time

Posted on:

Location Type: Office

Location: Santa ClaraCaliforniaUnited States

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Salary

💰 $81,500 - $141,300 per year

About the role

  • Prepares robust regulatory applications for FDA or international regulatory agencies
  • Provides regulatory input to product lifecycle planning
  • Evaluates proposed preclinical, clinical, and manufacturing changes
  • Acts as core team member for regulatory assessments
  • Interfaces directly with FDA and other regulatory agencies
  • Complies with FDA and international regulations

Requirements

  • Bachelor's degree or equivalent combination of education and work experience
  • Minimum of 2 years’ experience in a regulated industry (e.g., medical products, nutritionals, pharma, food)
  • Strong verbal and written communications skills
  • Ability to write and edit technical documents
  • Experience working with cross-functional teams
  • Attention to detail and ability to leverage, manage and engage others
Benefits
  • Free medical coverage in the Health Investment Plan (HIP) PPO medical plan
  • Excellent retirement savings plan with a high employer contribution
  • Tuition reimbursement
  • Freedom 2 Save student debt program
  • FreeU education benefit - an affordable path to getting a bachelor’s degree
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory applicationstechnical document writingregulatory assessmentspreclinical evaluationclinical evaluationmanufacturing changes evaluation
Soft Skills
verbal communicationwritten communicationattention to detailcross-functional teamworkengagement skills
Certifications
Bachelor's degree