Senior Director, Regulatory Affairs

divh2Senior Director, Regulatory Affairs/h2pThe Senior Director, Regulatory Affairs is a key strategist, responsible for developing regulatory strategy for the Endoscopy business unit and delivering Strykers best-in-class visualization and connectivity products to market in the United States, Canada and Europe. Through close partnership with business unit leadership, Marketing, RD, Clinical and Quality teams, the Senior Director and team will develop and advise on product positioning, product entry and exit strategies, among others./ppKey Areas of Responsibility:/pulliEnsure divisional achievement of quality, regulatory, and compliance targets/liliDirect activities to ensure new product development and product sustainment meet regulatory requirements/liliDevelop, lead, and execute a regulatory strategy ensuring that it is appropriate and effective in meeting the business needs/liliResponsible for the selection, supervision, development and objective-setting for team members/liliDevelop best practices to ensure compliance and drive revenue through improved customer experience/liliProvide a platform for process improvement/liliMay serve as alternate Management Representative/liliDefine targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets/liliRecruit, select, and on-board top talent/liliDevelop talent within team to increase performance/liliActively address performance issues on team/liliMaintain a high level of team engagement/liliLeads advocacy activities of a more advanced and global strategic nature/li/ulpEducation / Work Experience:/pulliBS in Engineering or other relevant field of study/liliMinimum of 10 years experience/liliMasters Degree or equivalent preferred/liliRAC desired/li/ulpKnowledge / Competencies:/pulliDemonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements/liliDemonstrated expertise in regulatory systems in a regulated environment/liliDemonstrated ability to manage complex projects/liliDemonstrated verbal, written, and interpersonal communication skills/liliDemonstrated ability to work in a team environment, interact effectively with management from other functions/liliDemonstrated ability to manage a multi-discipline, multi-technology, team-based organization and assume responsibility of quality, regulatory, and compliance targets/liliDemonstrated ability to initiate work/liliDemonstrated analytical ability/liliDemonstrated ability to make effective decisions/liliExperience with recruiting, people development/liliInfluence across the organization/li/ulpSalary: $171,500 - $379,000 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 ADD insurance, and short-term disability insurance./ppStryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role. 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./p/div