Job Boards Template

Search Jobs

Regulatory Compliance Business Analyst IT

Sunnyvale, CA 94086

Posted: 05/26/2023 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:
  • 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.

Meet Your Recruiter

Kalyan Krishna

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.