Regulatory Compliance Business Analyst It

• 6 Month contract opportunity - W2 (No C2C)
• Hybrid: 1090 Kifer Road, Sunnyvale, CA, 94086
• Compensation: $ 50- $74.08/hr

Primary Function of Position:

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

Roles & Responsibilities:

• 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
• Understand and interpret regulatory requirements, industry standards, and best practices for medical device companies
• Manage the implementation of new systems and processes, and ensure proper training and documentation is provided to all stakeholders
• 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

Skills, Experience, Education, & Training:

• Implementation experience with IT systems like SAP and TrackWise
• 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
• 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 understanding of regulatory requirements and industry standards for medical devices
• Strong project management skills and experience leading cross-functional teams
• Knowledge of EU MDR guidelines.
• Excellent communication and presentation skills, with the ability to effectively communicate with all levels of the organization
• Bachelor's degree in a related field, such as business, engineering, or science