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Regulatory Compliance Business Analyst IT
Sunnyvale, CAAmick 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
Responsibilities
Qualifications
Regular full-time employees are eligible for the following Amick Brown provided benefits:
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
Responsibilities
- 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
Qualifications
- 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
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