Stryker · 2 weeks ago
Principal Specialist, International RA
San Jose, CA
Full-time
Hybrid
Senior Level, Lead/Staff
$126K/yr - $274K/yr
8+ years expStryker is a company that focuses on regulatory excellence to enable innovation in medical technologies. As a Principal Specialist in International Regulatory Affairs, you will be responsible for shaping global regulatory strategies and ensuring timely market access while protecting patients and communities.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Develop and maintain global, regional, and multi‑country regulatory strategies aligned with business and product lifecycle objectives to achieve timely market access
Evaluate global regulatory trends, stakeholder expectations, and evolving requirements to inform long‑range regulatory planning and risk mitigation
Identify regulatory pathways for new and existing product designs; assess adequacy of proposed strategies and recommend refinements based on regulatory outcomes
Guide cross‑functional teams on regulatory considerations for product entry, exit, labeling, claims, and data requirements, ensuring submission readiness
Lead negotiations and sustained interactions with regulatory authorities across development, approval, and post‑approval phases to resolve complex issues
Assess regulatory impacts of clinical, preclinical, and manufacturing changes and determine submission or non‑submission approaches
Oversee preparation and approval of high‑quality electronic and paper regulatory submissions to achieve on‑time global filings
Prepare teams for regulatory inspections, audits, advisory panels, and authority meetings, supporting successful outcomes and renewals
Qualification
Required
Bachelor's degree in Engineering, Science, or a related field
8+ years of professional experience, including work in medical device regulatory affairs or a closely related field
Preferred
Master's degree in Regulatory Science or related field
Regulatory Affairs Certification (RAC)
Experience developing global, multi‑country regulatory strategies for devices addressing serious or life‑threatening conditions or unmet needs
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