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