Medical Device Project Manager – Regulatory & Market Expansion

Job Title : Medical Device Project Manager – Regulatory & Market Expansion

Location : Raritan , NJ

Long term Contract

JD :

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
Keyword:
Skills: EIS : Medical Device & Regulations~Project Management
Experience Required: 6-8