Senior Director, Regulatory Affairs

The Senior Director, Regulatory Affairs is a key strategist, responsible for developing regulatory strategy for the Endoscopy business unit and delivering Stryker’s best-in-class visualization and connectivity products to market in the United States, Canada and Europe. Through close partnership with business unit leadership, Marketing, R&D, Clinical and Quality teams, the Senior Director and team will develop and advise on product positioning, product entry and exit strategies, among others.

• 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
• May serve as alternate Management Representative
• 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
• Leads advocacy activities of a more advanced and global strategic nature

• 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
• Demonstrated verbal, written, and interpersonal communication skills
• Demonstrated ability to work in a team environment, interact effectively with management from other functions
• Demonstrated ability to manage a multi-discipline, multi-technology, team-based organization and assume responsibility of quality, regulatory, and compliance targets
• Demonstrated ability to initiate work
• Demonstrated analytical ability
• Demonstrated ability to make effective decisions
• Experience with recruiting, people development
• Influence across the organization

$171,500 - $379,000 salary plus bonus eligible + generally eligible for short-term and long-term financial incentives + benefits. Individual pay is based on skills, experience, and other relevant factors.