Stryker · 1 month ago
Senior Director, Regulatory Affairs
California, United States
Full-time
Onsite
Director/Executive
$172K/yr - $379K/yr
10+ years expStryker is a leading company in the medical device industry, and they are seeking a Senior Director of Regulatory Affairs to develop regulatory strategies for their Endoscopy business unit. The role involves ensuring compliance with regulatory standards, leading a team, and driving revenue through improved customer experience.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
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
Qualification
Required
BS in Engineering or other relevant field of study
Minimum of 10 years' experience
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
Preferred
Master's Degree or equivalent preferred
RAC desired
Benefits
Medical and prescription drug insurance
Dental insurance
Vision insurance
Critical illness insurance
Accident insurance
Hospital indemnity insurance
Personalized healthcare support
Wellbeing program
Tobacco cessation program
Health Savings Account (HSA)
Flexible Spending Accounts (FSAs)
401(k) plan
Employee Stock Purchase Plan (ESPP)
Basic life and AD&D insurance
Short-term disability insurance
Company
Stryker
Stryker is a medical technology company that offers products and services in orthopaedics.
10001+ employees
H1B Sponsorship
Stryker has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (105)
2024 (76)
2023 (63)
2022 (78)
2021 (57)
2020 (77)
Funding
Current Stage
Public CompanyTotal Funding
unknown1990-01-02IPO
Leadership Team
Kevin Lobo
Chair & CEO
Glenn S. Boehnlein
Chief Financial Officer and Vice President
Recent News
GlobeNewswire News Room
2025-02-11
Company data provided by crunchbase