Stryker · 8 hours ago
Senior Regulatory Affairs Specialist (Hybrid)
Flower Mound, TX
Full-time
Hybrid
Mid, Senior Level
2+ years expStryker is a company that offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine. They are seeking a Senior Regulatory Affairs Specialist to support new product development and regulatory compliance throughout the product lifecycle for both US and OUS global regulatory release.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Evaluates engineering changes to existing products to determine regulatory impact. Creates and updates regulatory deliverables as needed
Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
Evaluates proposed products for regulatory classification and jurisdiction
Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
Helps train stakeholders on current and new regulatory requirements to ensure organization wide compliance
Assists other departments in the development of SOPs to ensure regulatory compliance
Provides regulatory input and technical guidance on global regulatory requirements to product development teams
Provides regulatory information and guidance for proposed product claims/labeling
Review collateral material associated with new launches and ongoing product support
Qualification
Required
Bachelor's degree (B.S. or B.A.) required
2+ years of working in an FDA regulated industry
2+ years of medical device regulatory affairs experience
Previous experience with Class I and II Medical Devices
Preferred
Bachelor's degree in Engineering, Biological Sciences or equivalent focus
RAC certification or Advanced Degree (Masters in Regulatory Affairs or Engineering)
Previous experience with software Medical Devices
Experience interacting with regulatory agencies
Demonstrated success in management of global regulatory strategy and submission activities
Applied knowledge of FDA and international medical device regulations/standards/directive (i.e. European Medical Device Regulations)
Ability to understand and explain detailed regulatory requirements among different countries and comply with constantly changing regulatory requirements
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