Senior Director of Regulatory Affairs developing regulatory strategies for Stryker's visualization and connectivity products. Collaborating with business leaders across teams to ensure compliance and market readiness.
Responsibilities
Ensure divisional achievement of quality, regulatory, and compliance targets
Direct activities to ensure new product development and product sustainment meet regulatory requirements
Develop, lead, and execute a regulatory strategy ensuring that it is appropriate and effective in meeting the business needs
Responsible for the selection, supervision, development and objective-setting for team members
Develop best practices to ensure compliance and drive revenue through improved customer experience
Provide a platform for process improvement
Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets
Recruit, select, and on-board top talent
Develop talent within team to increase performance
Actively address performance issues on team
Maintain a high level of team engagement
Requirements
BS in Engineering or other relevant field of study
Minimum of 10 years’ experience
Master's Degree or equivalent preferred
RAC desired
Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements
Demonstrated expertise in regulatory systems in a regulated environment
Demonstrated ability to manage complex projects
Experience with recruiting, people development
Benefits
salary plus bonus eligible
generally eligible for short-term and long-term financial incentives
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