Pay Rate Range: $30.96 - 34.59/hr.
Job Description:Must Have Technical/Functional Skills
Ø Experience managing medical-device market expansion projects, including entry of existing products into new countries or regions and coordination of registration and launch readiness.
Ø Proficiency in project charters, scope definition, work breakdown structures, integrated schedules, critical-path analysis, resource planning, budget tracking, and governance reporting.
Ø Working knowledge of ISO 13485, ISO 14971, FDA Quality Management System Regulation (QMSR; 21 CFR Part 820), EU MDR, and country-specific registration requirements relevant to the target markets.
Ø Ability to coordinate Regulatory Affairs, Quality Assurance, R&D, Clinical Affairs, Medical Affairs, Manufacturing, Supply Chain, and regional commercial teams, with clear deliverable ownership.
Ø Understanding technical documentation and design and development records, including DHF documentation where used, risk management, verification and validation evidence, labeling, instructions for use, and packaging documentation.
Ø Understanding post-market surveillance and PMCF activities, and SSCP preparation
Ø Experience managing risks, assumptions, issues, dependencies, change control, document review cycles, and submission-readiness across multiple products and markets.
Ø Proficiency in project scheduling and reporting tools such as Microsoft Project, Excel, PowerPoint
Desirable: Ø Experience with orthopedic implants, surgical instruments, or other regulated medical-device portfolios. Ø Exposure to regional regulatory submissions, notified-body review coordination Ø Familiarity with UDI and device registration, labelling localization, and product lifecycle management systems. Ø Familiarity with PLM system such as Wndchill.
Roles & Responsibilities
· Lead end-to-end planning and execution of medical-device market expansion projects, from project initiation and market-specific gap assessment through registration, launch readiness.
· Develop and maintain an integrated project plan covering regulatory strategy and submissions, technical documentation, clinical evidence, labeling and localization, manufacturing and supply readiness, and commercial launch dependencies.
· Coordinate market-specific documentation gap assessments with Regulatory Affairs, Quality, R&D, Clinical Affairs, and Medical Affairs
· Manage schedules, resources, budget forecasts, and critical-path dependencies; maintain risks, assumptions, issues, and dependencies logs and escalate constraints with mitigation options.
· Facilitate cross-functional working meetings and governance reviews; communication status, decisions, actions
Generic Managerial Skills, If any
· Strong cross-functional leadership and ability to influence stakeholders in an organization
· Strong written and verbal communication skills, with the ability to provide clear, concise updates to senior leadership,
facilitate meetings, and accurately document key decisions.
· Ability to negotiate with stakeholders to secure the required resources and adjust project plans when deadlines change.
· Ability to solve problems systematically, make decisions based on risk, escalate issues promptly, and resolve conflicts
· Ability to coordinate geographically distributed teams and maintain accountability for agreed actions and deliverables.
Key Words to search in Resume
Medical Device Project Manager; Market Expansion; Market Entry; Product Registration; Launch Readiness; Regulatory Affairs Coordination; EU MDR; FDA QMSR; ISO 13485; Technical Documentation; DHF; PMP
Skills: EIS : Medical Device & Regulations~Project Management
Experience Required: 6-8 years
| Skills: | | Category | Name | Required | Importance | Experience |
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| SkillCategoryTest1_MN | EIS : Medical Device & Regulations | Yes | 1 | >7 years | | | SkillCategoryTest1_MN | Healthcare Project Management | Yes | 1 | >7 years | | | SkillCategoryTest1_MN | Project Management | Yes | 1 | >7 years | |
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