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EU MDR Program Manager
EU MDR Program ManagerAvanos • Alpharetta, GA, US
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EU MDR Program Manager

EU MDR Program Manager

Avanos • Alpharetta, GA, US
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EU MDR Program Manager

Here at Avanos Medical, we passionately believe in three things :

  • Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do;
  • Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation;
  • Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world.

At Avanos you will find an environment that strives to be independent and different, one that supports and inspires you to excel and to help change what medical devices can deliver, now and in the future. Avanos is a medical device company focused on delivering clinically superior breakthrough solutions that will help patients get back to the things that matter. We are committed to creating the next generation of innovative healthcare solutions which will address our most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Headquartered in Alpharetta, Georgia, we develop, manufacture, and market recognized brands in more than 90 countries. Avanos Medical is traded on the New York Stock Exchange under the ticker symbol AVNS.

The role :

You will be a member of the Enterprise PMO team that supports the planning and execution of transformation programs within Avanos. The role will serve as the program leader for high-profile, business-critical projects / programs including, but not limited to, EU MDR Program. In this role, you will work closely with cross functional teams, including regulatory, quality, clinical, R&D and manufacturing to ensure timely and effective program compliance. This role is hybrid requiring 2-3 days / week in the Alpharetta office.

Essential Duties and Responsibilities :

  • Drive and execute complex projects / programs with excellence through all project stages (Initiation, Planning, Executing, Monitoring and Controlling, and Closing).
  • Provide overarching leadership of programs that may contain several project workstreams.
  • Monitor and report on program progress, identifying and mitigating risks
  • Manage stakeholder and project communication regarding program decisions, direction, and issues (includes updates to leadership, stakeholder alignment on project scope and milestones, and escalation of issues and risks).
  • Must have the ability to communicate effectively at the C-Suite Level.
  • Coordinate internal and external resources, ensuring project deliverables remain within scope, schedule, and within defined budgets, in collaboration with project staff from various functional departments including marketing, quality, clinical, regulatory, design, human factors, packaging, process development, procurement, etc.
  • Ability to deep dive into program issues to provide resolution alongside Subject Matter Experts.
  • Your qualifications :

  • Experience in medical device program management or similar role, successfully managing EU MDR implementation or related programs.
  • Education : BS or advanced degree in engineering, or other related technical discipline.
  • Experience : 3 to 5 years' experience in the medical device industry and quality management systems experience; 3+ years of industry experience in project management; regulated medical device experience highly preferred.
  • Certification(s) / License(s) : Project Management Certification or equivalent preferred.
  • Strong and broad skills using the tools and technique of project management (WBS, risk register, issues log, budget forecasting, etc.).
  • Understanding of the total product lifecycle, with emphasis on the regulated design process.
  • Ability to lead in the face of ambiguity.
  • Ability to lead large cross-functional teams and drive execution and accountability to ensure on time delivery of key project milestones.
  • Outstanding communication and presentation skills (written and verbal) to all levels of an organization.
  • Must be adept at planning, interpersonal skills, conflict resolution, and organizing teamwork.
  • Domestic and / or International travel as needed (approximately 20%)
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