Senior Project Manager, International Regulatory Affairs

San Jose, CA / Flower Mound, TX / Kalamazoo, MI

Stryker is hiring a Senior Project Manager, International Regulatory Affairs, to expand global access to our Endoscopy division product portfolio within APAC. In this strategic leadership role, you will oversee the development and execution of complex market access strategies, leveraging advanced project management practices in areas such as regulatory, quality, risk, procurement, and stakeholder engagement. You will collaborate closely with business unit and cross functional leadership, regulatory teams, and global partners to drive alignment, ensure compliance, and deliver high-impact results.

What you will do:

• Lead the team in the development of the project charter and management plan. Direct, manage, monitor, and control project. Evaluate tradeoffs within project. Collaborate with project stakeholders to develop, manage and own project scope. Create detailed Work Breakdown Structure.
• Develop and manage the detailed project Gantt chart. Analyze critical path, major workstreams, and intersecting milestones. Own the project schedule Collaborate with cross-functional managers to define project budget. Monitor and maintain costs within budget.
• Partner with project team to create project Quality Plans using 2-3 quality planning tools and techniques. Monitor and maintain plans.
• Develop a risk management plan for the project. Identify, analyze, and understand project risks; develop and monitor a risk response plan.
• Develop a Procurement Management Plan and collaborate on the selection of procurement partners.
• Estimate, acquire and assign cross functional project resources. Define the role, responsibility, and deliverables for each team member. Provide direct feedback to the functional manager on performance reviews.
• Develop a Stakeholder management plan for the project, based on the identification, analysis and understanding of Stakeholder expectations.
• Develop and execute the communications management plan for project team and the needs of key stakeholders
  
  

What you need:

Basic Qualifications:

• Bachelor’s degree in Science, Engineering, or a related field
• 6+ years of experience in a regulated environment (Medical Device, Pharmaceutical, Biomedical, or Automotive).
• Experience leading and developing teams.
  
  

Preferred Qualifications:

• PMP certification or strong project management experience.
  
  

$130,700.00 - $215,300.00 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.