Stryker · 6 hours ago
Senior Regulatory Affairs Specialist (Hybrid)
Portage, MI
Full-time
Hybrid
Mid, Senior Level
2+ years expStryker is a leading company in medical technology, and they are seeking a Senior Regulatory Affairs Specialist to support their Acute Care portfolio for the global market. The role involves maintaining global market access, analyzing device modifications, and ensuring compliance with regulatory requirements for new product development.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Evaluate device modifications and takes appropriate action to ensure global product compliance
Support new product development in submitting registrations and subsequently support registration renewals in global markets
Analyze and advise on the impact of emerging regulatory intelligence
Provide regulatory input and technical guidance on global regulatory requirements to product development teams
Determine requirements and options for global regulatory submissions, approval pathways, and compliance activities
Prepare and submits regulatory submissions according to applicable regulatory requirements and guidelines in global markets
Participate in preparation and execution of audit required to enable of maintain market access
Identify the need for new regulatory procedures, SOPs, and participates in development and implementation
Qualification
Required
Bachelor's degree
2+ years of experience in an FDA or highly regulated industry
2+ years of full-time work experience in Regulatory Affairs and/or Quality Systems
Demonstrated ability to analyze and resolve non‑routine regulatory issues using independent judgment
Ability to manage multiple priorities and adapt to changing regulatory requirements
Preferred
Bachelor's degree (B.S. or B.A.) in Science, Engineering, or a related discipline
Experience supporting Class II and/or Class III medical devices
Experience authoring or supporting FDA 510(k) submissions
Prior experience interacting directly with regulatory agencies
Experience authoring global regulatory submissions for product approval
RAC certification or an advanced degree (e.g., Master's in Regulatory Affairs)
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