Senior Director, Regulatory Affairs
About The Position
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. This leader can be based remotely in the United States and will require roughly 25% travel, specifically including one week per month to San Jose, CA area expected.
Requirements
- BS in Engineering or other relevant field of study
- Minimum of 10 years’ experience
- 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
Nice To Haves
- Master's Degree or equivalent preferred
- RAC desired
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
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Director
