Senior Program Manager, EU MDR

Requisition ID:6268

Job Title:Senior Program Manager, EU MDR

Job Country:United States (US)

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

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  Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do;

  
  
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  Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation;

  
  
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  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.

The Avanos COVID-19 Vaccine Policy: This Policy applies to U.S. customer-facing / field-based employees & Avanos leadership: All U.S. customer-facing / field-based employees hires must be fully vaccinated against COVID-19. Proof of being fully vaccinated does not need to be disclosed until a job offer has been made but must be submitted within 48 hours after the acceptance of the job offer. If you have a qualifying medical condition or sincerely held religious belief or practice that precludes you from receiving a COVID-19 vaccine, you may apply for an exemption or deferral after you accept the job offer and before your scheduled start date. The reasonable accommodation provided to the employee, if any, will depend on the employee's job and the applicable facts, but it may include weekly COVID-19 testing and masking requirements. New hires who do not submit, before their scheduled start date, proof of being fully vaccinated or a request for a reasonable accommodation will have their job offer revoked.

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. For more information, visit www.avanos.com.

The role

You will be a member of the Enterprise Project Management Office 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, business integrations, divestitures, and enterprise-wide operational initiatives. 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.

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

Required:

• Experience in a leadership role successfully managing EU MDR implementation or related programs (2+ years preferred)
• Education: BS or advanced degree in engineering, or other related technical discipline
• Experience: 8 to 10 years' experience in the medical device industry and quality management systems experience; 8+ years of industry experience in project management; regulated medical device experience highly preferred.
• Certification(s) / License(s):Project Management Certification or equivalent required
• 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.
• Ability to travel up to 25% at times, potentially some international

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.

Avanos Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law. If you are a current employee of Avanos, please apply here .

Join us at Avanos

Join us and you can make a difference in our products, solutions and our culture. Most of all, you can make a difference in the lives, people, and communities around the world.

Make your career count

Our commitment to improving the health and wellbeing of others begins with our employees - through a comprehensive and competitive range of benefits. We provide more than just a salary - our Total Rewards package encompasses everything you receive as an employee; your pay, health care benefits, retirement plans and work/life benefits.

Avanos offers a generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting.

free onsite gym | benefits on day 1 | HQ region voted 'best place to live' by USA Today