Stryker ยท 1 month ago
Senior Regulatory Affairs Specialist (Hybrid)
Redmond, WA
Full-time
Hybrid
Mid, Senior Level
$89K/yr - $142K/yr
3+ 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 maintain medical devices on the market and ensure ongoing compliance within the Medical Division.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Support R&D, Marketing and Manufacturing teams with regulatory assessments of proposed changes or product transfers
Identify requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
Assist in the development of regulatory strategy and updates strategy based upon regulatory changes
Evaluate proposed products for regulatory classification and jurisdiction
Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
Prepare and submit electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines for required products
Provide regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
Communicate and interact with regulatory authorities throughout the development and review process of a regulatory submission through appropriate communication tools
Evaluate proposed pre-clinical, clinical, and manufacturing changes for regulatory filing solutions and propose plans/strategies (if appropriate) for changes that do not require submissions
Identify, monitor, and submit applicable reports or notifications to regulatory authorities during the clinical research process
Maintain current product registrations and assist with processing registration changes when required
Qualification
Required
Bachelor's degree in an Engineering, Science, or equivalent field
Minimum of 3 years of experience in an FDA or highly regulated industry required
Minimum of 2 years in a Regulatory Affairs role required
Preferred
RAC certification or Advanced Degree (Masters in Regulatory Affairs)
Previous experience with US Class II/III medical devices
Experience authoring regulatory submissions for product approval
Experience interacting with regulatory agencies
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