Description
Job Title: Project Manager - EU MDR / Manufacturing
Duration: Contract
Location: Arlington, TN - Hybrid, Monday-Friday, 8:00 AM-5:00 PM
Required Pay Scale:
- Due to client requirements this role is only open to USC or GC candidates
Job Summary:
We are seeking an experienced Project Manager to lead a cross-functional team responsible for implementing EU MDR (European Medical Device Regulation) requirements from a manufacturing perspective at a manufacturing site in Arlington, TN.
The Project Manager will develop and execute the project management plan, manage project schedules and budgets, identify and mitigate risks, coordinate cross-functional activities, and provide regular project updates to stakeholders.
This is an individual contributor role requiring strong independent judgment, professional expertise, attention to detail, and the ability to manage complex projects with minimal supervision.
Project Details:
- Lead the implementation of EU MDR requirements for the manufacturing site.
- Develop, maintain, and execute a comprehensive project management plan.
- Lead cross-functional teams across Manufacturing, Quality, Regulatory, Engineering, Operations, Supply Chain, and other relevant functions.
- Establish project timelines, milestones, deliverables, dependencies, and priorities.
- Manage project schedules and monitor progress from project initiation through delivery/implementation.
- Identify project risks, issues, and dependencies and develop appropriate mitigation strategies.
- Monitor project budgets, resources, and overall project performance.
- Organize and lead cross-functional project meetings and interdepartmental working sessions.
- Maintain clear communication with stakeholders and provide regular project status updates.
- Coordinate activities between internal teams and ensure deliverables remain on schedule and within budget.
- Analyze project information and apply sound judgment to resolve issues as they arise.
- Work independently with minimal supervision while maintaining strong attention to detail.
- Ensure project execution supports applicable regulatory, quality, and manufacturing requirements.
Must Haves
- 4+ years of Project Management experience.
- Hands-on experience with EU MDR (European Medical Device Regulation).
- Experience implementing EU MDR requirements within a manufacturing environment/site.
- Experience within medical device, MedTech, life sciences, pharmaceutical, or other highly regulated manufacturing environments.
- Strong experience leading cross-functional teams and projects.
- Experience developing and executing project plans, schedules, milestones, and deliverables.
- Strong risk identification, mitigation, issue management, and dependency management experience.
- Experience with stakeholder management and project status reporting.
- Strong communication, organizational, analytical, and problem-solving skills.
- Ability to work independently and make sound decisions with minimal supervision.
- Bachelor's degree or equivalent combination of education and professional experience.
- Must be able to work hybrid in Arlington, TN, Monday-Friday, 8:00 AM-5:00 PM.
Desired Skills
- Medical device manufacturing experience.
- Regulatory Affairs / Quality / Compliance project experience.
- Experience with ISO 13485, FDA, GMP, or other medical-device regulatory frameworks.
- Experience coordinating Manufacturing, Quality, Regulatory Affairs, Engineering, Operations, and Supply Chain teams.
- Experience managing project budgets and resource allocation.
- Change management and process improvement experience.
- Experience with project management methodologies and tools.
- Experience managing complex, multi-department regulatory implementation projects.
- PMP certification or equivalent project management credentials.
- Strong presentation and executive stakeholder communication skills.
About Matlen Silver
Experience Matters. Let your experience be driven by our experience. For more than 40 years, Matlen Silver has delivered solutions for complex talent and technology needs to Fortune 500 companies and industry leaders. Led by hard work, honesty, and a trusted team of experts, we can say that Matlen Silver technology has created a solutions experience and legacy of success that is the difference in the way the world works.
Matlen Silver is an Equal Opportunity Employer and considers all applicants for all positions without regard to race, color, religion, gender, national origin, age, sexual orientation, veteran status, the presence of a non-job-related medical condition or disability, or any other legally protected status.
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at email and/or phone at: [email protected] // 908-393-8600
At The Matlen Silver Group, Inc., W2 employees are eligible for the following benefits:
- Health, vision, and dental insurance (single and family coverage)
- 401(k) plan (employee contributions only)