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Regulatory Compliance Business Analyst IT

Sunnyvale, CA
Amick Brown is seeking an experienced Regulatory Compliance Business Analyst IT for our direct client.
Location: Sunnyvale, CA
Duration: 6 Months. 
Estimated pay range: $ 38.66  - $ 48.33 an hour per client contract and candidate skills, experience and work location.

Job Description
  • IT person who worked in Medical device company with some experience on TrackWise, SAP and PLM systems.
  • Business Analyst Role primarily focusing on the enablement of Regulatory, Quality and Compliance Systems.
  • Responsible for interfacing with Quality and Regulatory affairs groups build process maps, gather requirements, and write specifications to enable or enhance CAPA, Non-Conformance, Complaints, Audit Management and other post market functions in Quality Management, ERP and PLM systems.
  • This role will be heavily involved in working on Quality Management System like TrackWise and platform to host EUMDR capability.
  • Role ensures compliance with evolving applicable Global Requirements and Regulations such as the MDSAP, EUMDR & UDI

  • Understand and interpret regulatory requirements, industry standards, and best practices for medical device companies
  • Analyze business processes and identify areas for improvement to ensure compliance with regulatory and quality standards
  • Work with cross-functional teams like ERP and PLM to design, develop, and implement solutions to meet regulatory and quality requirements
  • Manage the implementation of new systems and processes, and ensure proper training and documentation is provided to all stakeholders
  • Monitor and maintain compliance with regulatory and quality standards, and provide regular updates to senior management
  • Serve as the subject matter expert for regulatory and quality systems, and provide guidance and support to other departments and teams

  • Bachelor's degree in a related field, such as business, engineering, or science
  • Minimum of 5 years' experience in a business systems analyst or related role, with a focus on regulatory and quality systems in a medical device or other regulated industry
  • Strong understanding of regulatory requirements and industry standards for medical devices
  • Knowledge of EU MDR guidelines.
  • Implementation experience with IT systems like SAP and TrackWise
  • Excellent analytical and problem-solving skills, with the ability to identify and implement solutions to complex problems.
  • Experience of RFP and vendor selection process.
  • Strong project management skills and experience leading cross-functional teams
  • Excellent communication and presentation skills, with the ability to effectively communicate with all levels of the organization
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: 
  • Health
  • Vision
  • Dental
  • 401k with company match
  • Paid time off
  • Sick Leave
  • long-Term Disability
  • Life Insurance
  • Wellness & Discount Programs


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