Public affairs [h1.location_city]

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. Key areas of responsibility include : ensuring divisional achievement of quality, regulatory, and compliance targets; directing activities to ensure new product development and product sustainment meet regulatory requirements; developing, leading, and executing 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; developing best practices to ensure compliance and drive revenue through improved customer experience; providing a platform for process improvement; may serve as alternate Management Representative; defining targets, KPIs, performance objectives, etc. for individuals within functional role, and managing direct reports to meet or exceed these targets; recruiting, selecting, and on-boarding top talent; developing talent within team to increase performance; actively addressing performance issues on team; maintaining a high level of team engagement; and leading 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; and influence across the organization.

$171,500 - $379,000 salary plus bonus eligible; generally eligible for short-term and long-term financial incentives; 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.