Search Jobs
Protingent
http://cdn.haleymarketing.com/templates/61820/logos/protingent-hml.png
http://www.protingent.com
http://www.protingent.com
true
Regulatory Compliance Business Analyst IT
1090 Kifer Road Sunnyvale, CA 94086 US
Posted: 05/26/2023
2023-05-26
2023-07-07
Employment Type:
Contract
Job Number: 27384
Job Description
Position Title: Regulatory Compliance Business Analyst IT
Position Description: Protingent Staffing has an exciting contract opportunity for a Regulatory Compliance Business Analyst IT with our client located in Sunnyvale, CA.
Job Responsibilities:
Job Qualifications:
Job Details:
Benefits Package: Protingent offers competitive salaries, 2 insurance plans (100% paid for employee only - HDHP plan, and a buy-up POS plan), education/certification reimbursement, pre-tax commuter benefits, Paid Time Off (PTO) and an administered 401k plan.
About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom, and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding, and exciting work opportunities for our candidates.
Position Description: Protingent Staffing has an exciting contract opportunity for a Regulatory Compliance Business Analyst IT with our client located in Sunnyvale, CA.
Job Responsibilities:
- 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 bestpractices 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.
Job 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 afocus 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.
Job Details:
- Contract
- Pay Range: $63-$68 /hr
Benefits Package: Protingent offers competitive salaries, 2 insurance plans (100% paid for employee only - HDHP plan, and a buy-up POS plan), education/certification reimbursement, pre-tax commuter benefits, Paid Time Off (PTO) and an administered 401k plan.
About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom, and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding, and exciting work opportunities for our candidates.