REGULATORY AFFAIRS SPECIALIST 3

Company: Veterans Sourcing Group
Location: Sunnyvale
Posted on: May 26, 2023

Job Description:

Job Title: Regulatory Affairs Specialist

Pay Rate: $48/hr
Location: Sunnyvale, CA
Duration: !2 Month Contract

Summary:

• 
  
• The Sr Regulatory Affairs Specialist is responsible for ensuring digital medical device regulatory clearance to enable market access by demonstrating compliance to applicable regulations through a registration dossier
  
  Roles and Responsibilities:
  
  
  • 
    
  • Provides regulatory guidance and defines regulatory strategy for digital products by translating complex regulatory concepts into understandable principles
    
  • Directs or performs coordination and preparation of document packages for complex medical device regulatory submissions based on company objectives and timelines
    
  • Leads or compiles all materials required in submissions, license renewal and annual registrations
    
  • Represents Intuitive's regulatory strategy with US FDA or other competent authorities
    
  • Supports regulatory strategy, labeling, manufacturing, marketing, and clinical protocol to achieve regulatory clearance.
    
  • Independently advises cross-functional teams and share knowledge and expertise to support development and training of team members
    
  • Supports clearance of non-medical devices
    
  • Ensures that company procedures, processes and documentation meet requirements of the Quality Management System, ISO 13485 and other applicable regulations
    
  • Implements and supports Quality Management system activities such as CAPA, management review and internal & external audits as needed
    
  • Other regulatory tasks and projects may be assigned as necessary
    
    Required Knowledge, Skills, and Experience:
    
    
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    • At least 8+ years of significant experience in regulatory affairs and quality compliance for medical devices according to EU regulation
      
    • A Bachelors or Master's degree in engineering, medical technology or similar preferred (or equivalent work experience in similar function)
      
    • In Depth knowledge of US FDA 21 CFR 820.30 and US clearance pathway (510(k)), including US FDA guidances on digital devices
      
    • Knowledge of European Medical Device Regulation (2017/745/EU)
      
    • Significant experience in design control, including new product development
      
    • Demonstrate organizational and planning skills, including action oriented, focus urgency and driving for results.
      
    • Demonstrate good interpersonal skills, ability to work with others in international team environment, effective interactions in cross department teams.
      
    • Ability to work autonomously, exercise daily judgment based on above regulatory knowledge
      
    • Orientation for work result details, with emphasis on accuracy and completeness
      
    • Fluent (C1 minimum) in written and spoken English
      
    • General Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook)
      
    • RAC certification
      
    • Prior experience working on Software as a medical device and/or digital technologies
      
    • Knowledge of non-medical device regulations (eg FCC, CE Marking, ---)
      

Keywords: Veterans Sourcing Group, Sunnyvale , REGULATORY AFFAIRS SPECIALIST 3, Other , Sunnyvale, California