Senior Director, Regulatory Affairs

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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.
All potential candidates should read through the following details of this job with care before making an application.
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 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
$223,000 - $379,000salary 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.
Health 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. Stryker 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. #J-18808-Ljbffr
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Location:
San Jose, CA
Salary:
$250
Category:
Management And Consultancy

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