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.
Key Areas of Responsibility:
- 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
Education / Work Experience:
- BS in Engineering or other relevant field of study
- Minimum of 10 years’ experience
- Master's Degree or equivalent preferred
- RAC desired
Knowledge / Competencies:
- 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.
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