Work Flexibility: Hybrid

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 is required to be based in San Jose, CA with a hybrid work schedule of three days per week in office. Relocation support can be provided.

Key Areas of Responsibility:

Ensure divisional achievement of quality, regulatory, and compliance targetsDirect activities to ensure new product development and product sustainment meet regulatory requirementsDevelop, lead, and execute a regulatory strategy ensuring that it is appropriate and effective in meeting the business needsResponsible for the selection, supervision, development and objective-setting for team membersDevelop best practices to ensure compliance and drive revenue through improved customer experienceProvide a platform for process improvementMay serve as alternate Management RepresentativeDefine targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targetsRecruit, select, and on-board top talentDevelop talent within team to increase performanceActively address performance issues on teamMaintain a high level of team engagementLeads advocacy activities of a more advanced and global strategic nature

Education / Work Experience:

BS in Engineering or other relevant field of studyMinimum of 10 years’ experienceMaster's Degree or equivalent preferredRAC desired

Knowledge / Competencies:

Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirementsDemonstrated expertise in regulatory systems in a regulated environmentDemonstrated ability to manage complex projectsDemonstrated verbal, written, and interpersonal communication skillsDemonstrated ability to work in a team environment, interact effectively with management from other functionsDemonstrated ability to manage a multi-discipline, multi-technology, team-based organization and assume responsibility of quality, regulatory, and compliance targetsDemonstrated ability to initiate workDemonstrated analytical abilityDemonstrated ability to make effective decisionsExperience with recruiting, people developmentInfluence across the organization

$223,000 - $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.

Travel Percentage: 20%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.