Senior Manager, Regulatory Affairs

Stryker•Irvine, CA

4d•$167,200 - $278,600•Hybrid

About The Position

Stryker is hiring a Senior Manager, Regulatory Affairs for their Peripheral Vascular division in Irvine, CA. This strategic people leader is responsible for driving global regulatory strategy and compliance across the full product lifecycle for Stryker's Peripheral Vascular portfolio. The role partners closely with cross-functional teams to ensure products meet U.S. and international regulatory requirements while supporting innovation, commercialization, and business growth. The Senior Manager leads regulatory operations, regulatory submissions and compliance activities, provides expert guidance on product changes and labeling, and develops a high-performing Regulatory Affairs team. This position plays a critical role in shaping regulatory strategy, influencing business decisions, and ensuring successful interactions with global regulatory authorities throughout the product lifecycle.

Requirements

Bachelor’s degree
Minimum 10+ years of experience within regulated environments, with expertise in interpreting and applying and international regulatory requirements throughout the product lifecycle.
Minimum 3 years of demonstrated experience in people leadership, including talent development, performance management, and team engagement.
Experience analyzing regulatory data, trends, and performance metrics to support compliance, risk management, and business decision-making.

Nice To Haves

Bachelor degree or higher in a Science or Engineering related discipline
Experience working within the medical device industry, including knowledge of FDA regulations and quality requirements.
Experience supporting regulatory submissions, including FDA 510(k) and/or EU MDR requirements.
Demonstrated project management experience, including planning, execution, timeline management, and cross-functional coordination.

Responsibilities

Support global regulatory strategy across the full product lifecycle, including development, post-market changes, and product obsolescence.
Provide regulatory guidance on product claims, labeling, IFUs, patient materials, and other product information to ensure compliance and accuracy.
Assess product, manufacturing, supplier, and clinical changes, determining regulatory impact, requirements, and submissions.
Monitor evolving regulatory requirements and evaluate their impact on products, business operations, and strategic initiatives.
Partner cross-functionally to integrate regulatory requirements into product development, quality, clinical, and business objectives.
Lead regulatory operations, including project management, timelines, metrics, reporting, processes, compliance programs, audits, inspections, and regulatory authority interactions.
Develop and deliver regulatory training while driving continuous improvement of regulatory systems, procedures, and organizational compliance.
Build, lead, and engage a high-performing Regulatory Affairs team through talent development, performance management, resource planning, budgeting, and forecasting.