Senior EU MDR Program Lead

ATR International; Minneapolis (MN); Vor Ort; USD 120.000 - 160.000; Vollzeit

Zusammenfassung

ATR International supports a medical device manufacturing client seeking a Principal Project Management Specialist to lead complex EU MDR implementation and compliance change-control projects for released products.

You will collaborate with Regulatory Affairs, Quality, Engineering, Operations, and external suppliers to translate requirements into executable plans, ensuring product availability and supply continuity.

Qualifikationen

• Bachelor’s degree with at least 7 years of relevant experience, or an advanced degree with at least 5 years.
• Experience leading complex, interdependent projects or programs in medical devices or regulated products.
• Ability to translate regulatory, quality, and business requirements into actionable plans.
• Direct experience working with OEMs, contract manufacturers, or external suppliers.
• Ability to manage integrated schedules, budgets, risks, dependencies, governance, and executive communications.
• Strong stakeholder management, negotiation, conflict-resolution, and communication skills.
• Ability to influence cross-functional teams and establish accountability without direct authority.
• Ability to work independently through ambiguity and changing priorities using structured problem solving.

Aufgaben

• Lead multiple MDR implementation and compliance projects from initiation to closure.
• Align cross-functional teams on objectives, deliverables, priorities, and execution plans.
• Develop integrated plans connecting technical deliverables with regulatory and quality requirements.
• Coordinate with OEMs and contract manufacturers on MDR transition planning.
• Manage changes to released products across components, processes, specs, packaging, labeling and quality systems.
• Oversee project scope, schedules, budgets, resources, risks, dependencies, governance and reporting.
• Use data to identify constraints and present options to stakeholders.
• Lead project meetings, document decisions, and track actions to ensure readiness.
• Communicate status, risks and decisions to teams and leadership.
• Strengthen PMO practices through lessons learned and continuous improvement.

Kenntnisse

Regulatory knowledge

Regulatory compliance

Project management

Stakeholder management

Cross-functional leadership

Ausbildung

Bachelor’s degree with 7+ years experience

Jobbeschreibung

ATR International supports a medical device manufacturing client seeking a Principal Project Management Specialist to lead complex EU MDR implementation and compliance change-control projects for released products.

You will collaborate with Regulatory Affairs, Quality, Engineering, Operations, and external suppliers to translate requirements into executable plans, ensuring product availability and supply continuity.