| medical devices Project manager: onsite CA or NJ: 50 per hr at Remote, Remote, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=3179622&uid=f88f946be1f04fa8a5d1331a55a4865b From: jay, Brillius [email protected] Reply to: [email protected] Job Description: Must Have Technical/Functional Skills 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. 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 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) Role Descriptions: Roles ResponsibilitiesEnsure 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 CRCN 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 RD| Marketing| Operations| Quality Assurance| and ClinicalRegulatory 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 andor Agile project management methodologies.Manage 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 Keywords: rlang microsoft mississippi California medical devices Project manager: onsite CA or NJ: 50 per hr [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=3179622&uid=f88f946be1f04fa8a5d1331a55a4865b |
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| 10:59 AM 03-Mar-26 |