Sr. Manager Regulatory Affairs

Stryker•Irvine, CA

1d•$167,000 - $278,600•Hybrid

About The Position

Join Stryker’s Peripheral Vascular division in Irvine, CA, where you’ll play a pivotal role in advancing life‑enhancing medical technologies. As a Senior Regulatory Affairs Manager - International, you will lead global regulatory strategies that accelerate patient access to innovative solutions and directly shape successful product launches across key international markets. This is an opportunity to make a measurable impact while developing a high‑performing team in a fast-moving, mission‑driven environment.

Requirements

Bachelor’s degree required. (Engineering, Science, or related field preferred).
Minimum 10 years of experience in an FDA‑regulated industry.
Minimum 3 years of people leadership experience.
Medical device industry experience required.

Nice To Haves

Master’s degree and/or Regulatory Affairs Certification (RAC).
Experience with international submissions across EMEA, EU, APAC, Latin America, and Canada.
Experience leading geographically dispersed teams.

Responsibilities

Lead day‑to-day global regulatory operations, ensuring activities are accurately evaluated, prioritized, and executed to meet business timelines.
Oversee preparation, review, and submission of regulatory filings supporting market access across EMEA, EU, APAC, and Latin America.
Manage regulatory processes for Patient‑Specific Solutions, including compassionate use and special access pathways.
Interpret global regulatory requirements and guide internal teams on submission strategies, labeling compliance, and product claims.
Ensure regulatory submissions, labeling, and marketing materials meet all applicable standards and internal quality expectations.
Represent Regulatory Affairs in internal and external audits with health authorities and Notified Bodies.
Partner with Quality, R&D, Supply Chain, Finance, Sales, and Marketing to drive cross‑functional alignment on regulatory deliverables.
Lead and develop a high‑performing Regulatory Affairs team, providing coaching, goal setting, issue resolution, and ongoing performance management.
Establish standardized regulatory processes with clear ownership and implement practical process improvements to reduce inefficiencies.
Track and report regulatory metrics, workload distribution, and submission timelines to support operational planning and budget management.