Senior PD Program Manager – EU MDR Leader

Responsibilities

Define and implement the EU MDR Globalization strategy aligned with regulatory requirements and business priorities.

Establish governance structures, decision frameworks, and operating mechanisms to support effective program execution.

Ensure alignment and coordination across MDR program workstreams.

Lead and develop a team responsible for key MDR transition workstreams, ensuring alignment, accountability, and coordinated execution across the program.

Drive alignment across cross‑functional teams and manage interdependencies across program workstreams.

Develop and maintain integrated program plans including milestones, dependencies, and risk mitigation strategies.

Monitor program progress and proactively address risks, issues, and constraints.

Manage program budgets and track financial performance against program plans.

Partner with cross‑functional leaders to maintain alignment on program priorities and regulatory commitments.

Define and monitor key performance indicators to assess program health and execution effectiveness.

Requirements

Bachelor’s degree with a minimum of 7 years of relevant experience OR advanced degree with a minimum of 5 years of relevant experience

5+ years leading complex cross‑functional programs in a matrixed environment

5+ years managing multiple concurrent projects or programs of increasing complexity

5+ years of experience managing program budgets or financial tracking

5+ years leading stakeholder communications across multiple organizational levels

5+ years directly managing or mentoring project managers or program team members

Experience working in the medical device, life sciences, or other regulated industry

Working knowledge of global medical device regulatory frameworks

Demonstrated ability to build or scale programs from concept through execution

Ability to operate effectively in complex and evolving environments

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