Regulatory Compliance Specialist

Company: Amick Brown, LLC
Location: Sunnyvale
Posted on: January 27, 2023

Job Description:

Amick Brown is seeking an experienced Regulatory Compliance Specialistfor our direct client.
Location: Sunnyvale, CA
Duration: 12 Months
Estimated pay range: $46.76 - $58.46 an hour per client contract and candidate skills, experience and work location
Description

• 
  
• This position will support ISI's Internal and External Audits to ensure compliance to regulatory and statutory requirements.
  
• This person will support activities of Third-Party visits and inspections (Notified Body, FDA etc.) focusing on backroom audit support.
  
• This individual must have knowledge of the various regulations and standards for medical devices including MDSAP (Medical Device Single Audit Program), FDA (US Food and Drug Administration) EU MDR 2017/745 (European Union Medical Device Regulation).
  
• The primary focus of this position will be FDA readiness and to ensure compliance with 21 CFR 820 quality management system regulations.
  
• Day to day activities may include:
  
• Planning, practice and preparation to ensure the successful execution of external audits
  
• Collaboration with process owners, with the goal to provide coaching and direction for subject matter expert in order to remediate any gaps or opportunities for improvement
  
• Support the internal audit program by participating in an audit or preparing for site audits
  
• Root cause analysis investigations, planning for corrective and preventive actions related to internal audit findings or gaps identified in the quality management system
  
• Review and approve internal audit finding corrective action plans
  
• Perform gap assessments to changes in regulations or standards
  
• May include analysis of data or metrics to support the internal audit program
  
  
  Required Skills
  
  • 
    
  • Bachelors' degree in Engineering or the Physical or Biological Sciences
    
  • Lead auditor certified (ISO 9001) to ISO 13485
    
  • 5 years in a Quality, Compliance or Regulatory role in the medical device or other regulated manufacturing environment.
    
  • Min. 3 years of experience managing quality system internal audits, providing front/backroom support for FDA inspections
    
  • Demonstrated problem-solving, and critical thinking skills
    
  • Strong organizational, written and verbal communication skills and the proven ability to prioritize tasks effectively in a deadline-driven environment. Strong people skills with focus on negotiation and arbitration factors.
    
  • Ability to work remote
    
  • Flexibility to travel - 25% (primarily Sunnyvale Headquarters and North America based manufacturing locations)
    
    Amick Brown is an Information Technology consulting company specializing in ERP, Data Analytics, Information Security, Application Development, Networking, and Cloud Computing. The company was founded in 2010 and is headquartered in San Ramon, California.
    Regular full-time employees are eligible for the following Amick Brown provided benefits:
    
    • 
      
    • Vision
      
    • Dental
      
    • 401k Health
      
    • with company match
      
    • Paid time off
      
    • Sick Leave
      
    • long-Term Disability
      
    • Life Insurance
      
    • Wellness & Discount Programs
      

Keywords: Amick Brown, LLC, Sunnyvale , Regulatory Compliance Specialist, Other , Sunnyvale, California