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Senior Regulatory Affairs Specialist

Company Name: Kavo Kerr
Location: Orange, CA
Job Type: Regulatory Affairs/Full-Time
Email: Apply Directly Online (see below)
Salary:

Job Description:  This position is responsible for assisting in the preparation and submission of domestic and/or global product registrations. The candidate must have a basic working knowledge of domestic and/or international medical device regulations, including 510k and international registration dossier submissions.  

Essential Duties and Responsibilities: 

  • Responsible for assisting in the preparation and compilation of domestic and international product registration submissions, with guidance.  This includes, but is not limited to, 510ks, international dossiers and CE technical files.
  • Responsible for agency establishment registrations and device/drug listings.
  • Support UDI and GUDID database operations
  • Responsible for FDA requests to ensure customs/trade compliance
  • Assist with the preparation and submission of FOAIs, FDA 513g requests, Certificates to Foreign Government and Pre-Submission applications.
  • Assist with the preparation and compilation of regulatory information requested during government audits/inspections, such as with FDA, Health Canada and Notified Body
  • Support domestic and international field corrective actions and adverse event reporting
  • Prepare monthly status reports, Key Performance Indicators (KPI) for Regulatory Affairs Management
  • Perform special projects as needed
  • Scope: Domestic and International 

Supervisory Responsibilities: This job has no supervisory responsibilities. 

Please apply here: https://danaher.taleo.net/careersection/external/jobdetail.ftl?lang=en&job=KAV002108

Job Requirements: 

Requirements:

  • Bachelor's Degree (BA/BS) from four-year college/university.  
  • 3-5 years regulatory experience.
  • 510k submissions experience. 

Preferred:

  • Excellent written and oral communication skills. 
  • Strong analytical and organizational skills; ability for detail and precision.  
  • Team player with ability to work independently.
  • Good general mathematical skills, strategies and concepts including the ability to calculate figures and amounts such as percentages.  
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • Must have the ability to work in a team-oriented environment and is able to meet tight deadlines.  Building internal working relationships with all department levels.  In the discretion of RA management, handles routine interactions with FDA and other regulatory agencies.
  • Minimal experience in adverse event reporting and/or field corrective actions preferred. 

Please apply here: https://danaher.taleo.net/careersection/external/jobdetail.ftl?lang=en&job=KAV002108