Medical Device Labeling project Manager
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Job Location:
Irvine, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
Medical Device Labeling Manager
Irvine CA
Strong expertise in Project & Portfolio Management methodologies (road mapping resource allocation risk management financial tracking).
Deep knowledge of Medical Device industry functional groups like labeling regulatory and manufacturing.
Advanced skills in Six Sigma and Value Stream Mapping for process optimization.
Experience with MRP systems and Production Planning (forecasting capacity planning scheduling).
Familiarity with Regulatory Compliance standards (medical devices pharma) and governance frameworks.
Strong leadership and mentoring capabilities for cross-functional teams.
Hands-on experience with PM tools (MS Project JIRA or similar) and data-driven decision-making frameworks.
Excellent Interpersonal / communication skills Organizational / planning and Project management skills preferred Personal computer skills Windows: word processing presentation e-mail web browsers & spreadsheet software Ability to work efficiently meet timelines and communicate status (generate trackers send emails etc.)
Irvine CA
Strong expertise in Project & Portfolio Management methodologies (road mapping resource allocation risk management financial tracking).
Deep knowledge of Medical Device industry functional groups like labeling regulatory and manufacturing.
Advanced skills in Six Sigma and Value Stream Mapping for process optimization.
Experience with MRP systems and Production Planning (forecasting capacity planning scheduling).
Familiarity with Regulatory Compliance standards (medical devices pharma) and governance frameworks.
Strong leadership and mentoring capabilities for cross-functional teams.
Hands-on experience with PM tools (MS Project JIRA or similar) and data-driven decision-making frameworks.
Excellent Interpersonal / communication skills Organizational / planning and Project management skills preferred Personal computer skills Windows: word processing presentation e-mail web browsers & spreadsheet software Ability to work efficiently meet timelines and communicate status (generate trackers send emails etc.)
Roles & Responsibilities
Ensure compliance with applicable Corporate and Divisional policies and procedures.
Develop communicate and execute integrated project plans (project charter schedule milestones budget risks issues) and monitor progress and performance. Resolve problems mitigate risk and minimize delays.
Identify scope develop timelines and align resources for labeling regulatory projects and windchill CR/CN process across multiple product lines and geographies. Manage multiple parallel projects with cross-functional teams.
Review labeling updates for content accuracy and alignment with regulatory and other requirements.
Estimate costs resources and durations required to complete projects including impacted products labels IFUs change
requests and change notification process; monitor activities allocate resources and assign tasks to meet objectives.
Serve as primary project and contact and interface with the Technical Leader (technical issues) Functional Manager (resource issues) and Executive Sponsor (project issues).
Liaise with internal stakeholders and external partners to secure specialized resources and contributions including
coordination with print vendors manufacturing stakeholders EMs and New Product Introduction (NPI) teams.
Facilitate cross-functional communication between R&D Marketing Operations Quality Assurance and Clinical/Regulatory
organizations.
Conduct project meetings and prepare status reports for the project team and leadership.
Drive problem solving for complex scenarios and benchmark strategies with project staff.
Analyze and evaluate tools and processes; propose and implement improvements to accuracy and efficiency.
Lead continuous improvement initiatives employing Six Sigma principles and/or Agile project management methodologies.
Manage complex label content for diverse medical device products and ensure timely closure of labeling-related tasks.
Ensure compliance with applicable Corporate and Divisional policies and procedures.
Develop communicate and execute integrated project plans (project charter schedule milestones budget risks issues) and monitor progress and performance. Resolve problems mitigate risk and minimize delays.
Identify scope develop timelines and align resources for labeling regulatory projects and windchill CR/CN process across multiple product lines and geographies. Manage multiple parallel projects with cross-functional teams.
Review labeling updates for content accuracy and alignment with regulatory and other requirements.
Estimate costs resources and durations required to complete projects including impacted products labels IFUs change
requests and change notification process; monitor activities allocate resources and assign tasks to meet objectives.
Serve as primary project and contact and interface with the Technical Leader (technical issues) Functional Manager (resource issues) and Executive Sponsor (project issues).
Liaise with internal stakeholders and external partners to secure specialized resources and contributions including
coordination with print vendors manufacturing stakeholders EMs and New Product Introduction (NPI) teams.
Facilitate cross-functional communication between R&D Marketing Operations Quality Assurance and Clinical/Regulatory
organizations.
Conduct project meetings and prepare status reports for the project team and leadership.
Drive problem solving for complex scenarios and benchmark strategies with project staff.
Analyze and evaluate tools and processes; propose and implement improvements to accuracy and efficiency.
Lead continuous improvement initiatives employing Six Sigma principles and/or Agile project management methodologies.
Manage complex label content for diverse medical device products and ensure timely closure of labeling-related tasks.
Generic Managerial Skills If any
Strong communication skills. Candidates must be highly proficient in reading writing and speaking English language.
Ability to multitask including ability to understand customer requirements retrieve relevant information and provide
responses satisfactorily and with immediacy is required.
Employee must be able to effectively prioritize and manage multiple activities and responsibilities.
Ability to understand and follow complex written procedures is required.
Ability to function in a team environment and deliver on team objectives is required.
Ability to make decisions and solve problems while exhibiting situational judgement.
Key Words to search in Resume
Labeling Regulatory Project QMS & Portfolio Management Supply Chain Management Manufacturing Continuous Improvement
Six Sigma Risk Management Regulatory Compliance (Medical Devices / Pharma) PMP or Project Management Certification
Leadership & Mentorship Cross-functional Team Management Strategic Planning Process Optimization
Strong communication skills. Candidates must be highly proficient in reading writing and speaking English language.
Ability to multitask including ability to understand customer requirements retrieve relevant information and provide
responses satisfactorily and with immediacy is required.
Employee must be able to effectively prioritize and manage multiple activities and responsibilities.
Ability to understand and follow complex written procedures is required.
Ability to function in a team environment and deliver on team objectives is required.
Ability to make decisions and solve problems while exhibiting situational judgement.
Key Words to search in Resume
Labeling Regulatory Project QMS & Portfolio Management Supply Chain Management Manufacturing Continuous Improvement
Six Sigma Risk Management Regulatory Compliance (Medical Devices / Pharma) PMP or Project Management Certification
Leadership & Mentorship Cross-functional Team Management Strategic Planning Process Optimization
Pre-Screening Questionnaire
How many years of experience does the candidate have in Medical Device Domain or Industry experience (Minimum
requirement is 6 years more than 6 is ideal).
Does the candidate have knowledge in Project & Portfolio Management process
Does the candidate have knowledge in Labeling / Regulatory / QMS windchill process
Does the candidate have knowledge in MRP & Production planning
Does the candidate have knowledge in Manufacturing process
Does the candidate have PMP Certifications
Is the candidate willing to relocate to Irvine CA (if required)
How many years of experience does the candidate have in Medical Device Domain or Industry experience (Minimum
requirement is 6 years more than 6 is ideal).
Does the candidate have knowledge in Project & Portfolio Management process
Does the candidate have knowledge in Labeling / Regulatory / QMS windchill process
Does the candidate have knowledge in MRP & Production planning
Does the candidate have knowledge in Manufacturing process
Does the candidate have PMP Certifications
Is the candidate willing to relocate to Irvine CA (if required)
Role Descriptions: Roles ResponsibilitiesEnsure compliance with applicable Corporate and Divisional policies and communicate and execute integrated project plans (project charter schedule milestones budget risks issues) and monitor progress and performance. Resolve problems mitigate risk and minimize scope develop timelines and align resources for labeling regulatory projects and windchill CRCN process across multiple product lines and geographies. Manage multiple parallel projects with cross-functional labeling updates for content accuracy and alignment with regulatory and other costs resources and durations required to complete projects including impacted products labels IFUs change requests and change notification process monitor activities allocate resources and assign tasks to meet as primary project and contact and interface with the Technical Leader (technical issues) Functional Manager (resource issues) and Executive Sponsor (project issues).Liaise with internal stakeholders and external partners to secure specialized resources and contributions including coordination with print vendors manufacturing stakeholders EMs and New Product Introduction (NPI) cross-functional communication between RD Marketing Operations Quality Assurance and ClinicalRegulatory project meetings and prepare status reports for the project team and problem solving for complex scenarios and benchmark strategies with project and evaluate tools and processes propose and implement improvements to accuracy and continuous improvement initiatives employing Six Sigma principles andor Agile project management complex label content for diverse medical device products and ensure timely closure of labeling-related tasks.
Essential Skills: Technical Project Manager (Strong in Medical devices labeling and regulatory projects execution).
Desirable Skills:
Keyword:
Skills: EIS : Medical Device & Regulations Project Management EIS : New Product Development (NPD) Methodology and Management Experience Required: 10 & Above
Essential Skills: Technical Project Manager (Strong in Medical devices labeling and regulatory projects execution).
Desirable Skills:
Keyword:
Skills: EIS : Medical Device & Regulations Project Management EIS : New Product Development (NPD) Methodology and Management Experience Required: 10 & Above
Thanks
Jay
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