Regulatory Documentation Specialist

Title : Quality Document Systems Management Specialist III

All candidates should make sure to read the following job description and information carefully before applying.

Location : Irvine, CA (Hybrid) – Position is open to Fully Remote candidates

Note : This is a W2 contract role – C2C & 3 rd party candidates WILL NOT be considered

• The Quality Document Systems Management Specialist will ensure appropriate and necessary documentation is in place to meet BD APM Quality System in compliance with regulatory requirements. The Quality Document Systems Management Specialist will;
• Evaluate changes proposed by initiators and provide feedback and recommendations for improvement and compliance
• Lead special projects (e.g., Project PaRTy) in collaboration with team members, identifying opportunities for change control process improvement, including developing and proposing solutions, and proposing new processes and system enhancements
• Coordinate and perform incorporation of approved changes to documentation (e.g. JDE process sheets, drawings, PNs, technical summaries, etc.) per BD APM change control process in PLM and other applicable systems
• Review change package against governing procedures and release final change package with increased complexity
• Train / assist team members on engineering change control workflow (CR / CN) structure and procedures
• Review all incoming PCNs and assess for material changes and datasheet updates
• Route PCNs with relevant changes to designated product owners
• Maintain a tracking system for PCNs reviewed, routed, and approved
• Collaborate with the Lifecycle Engineering team to refine triage criteria and improve efficiency
• Ensure compliance with internal documentation and approval standards
• Handle other duties, as assigned by leadership

Position Qualifications :

Note : This is a W2 contract role – C2C & 3 rd party candidates WILL NOT be considered