Stryker Corporation

Senior Manager, Regulatory Affairs

Stryker Corporation • $167K — $278K *
Irvine, CA 92620In-Person
Healthcare
8 - 10 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree
  • 10+ years experience in regulated environments with international regulatory expertise
  • 3+ years of people leadership experience
  • Experience in analyzing regulatory data and performance metrics
  • Preferred: Degree in Science or Engineering
  • Preferred: Medical device industry knowledge including FDA regulations
  • Preferred: Experience with regulatory submissions like FDA 510(k) and EU MDR

Responsibilities

  • Lead global regulatory strategy across the full product lifecycle
  • Provide regulatory guidance on product claims, labeling, and patient materials
  • Assess changes for regulatory impact and determine submission requirements
  • Monitor evolving regulatory requirements and their business implications
  • Integrate regulatory requirements into development and business objectives
  • Manage regulatory operations including compliance programs and audits
  • Develop and deliver training for regulatory systems and compliance
  • Build and engage a high-performing Regulatory Affairs team

Benefits

  • Hybrid work flexibility with in-office presence required 3 days a week
  • Opportunity for continuous professional development
  • Engagement with cross-functional teams to influence business growth
  • Support for innovation and commercialization in the regulatory space
  • High-impact role shaping regulatory strategy and interactions with global authorities
Full Job Description
Work Flexibility: Hybrid

The Senior Manager, Regulatory Affairs is a strategic people leader responsible for driving global regulatory strategy and compliance across the full product lifecycle for Stryker's Peripheral Vascular portfolio. This 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, manages 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.

Workplace Flexibility: This is a hybrid role requiring the candidate to be within commuting distance to Irvine, CA. The work schedule is structured to support flexibility, with in-office presence required 3 days/week and remote work available the rest of the week. To qualify, candidates must be able to commute to the facility as needed.

What you will do
  • Lead 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.


What you need

Required Qualifications:
  • 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.

Preferred Qualifications:
  • 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.


US15: $167,200 - $278,600 USD Annual

Travel Percentage: 10%

About Stryker Corporation

Stryker Networks is a premier Information Technology partner providing IT managed services and database application development.

Stryker Corporation Careers

Joining Stryker Corporation means becoming part of a global team recognized for its commitment to innovation, leadership, and enhancing patient outcomes. As a leading medical technology company, Stryker is the perfect place to build a career that truly makes a difference.

Work You’ll Do

At Stryker, every position contributes to our mission of making healthcare better. Here, you will use your skills to work on transformative projects that improve lives across the globe. You will be part of a culture that thrives on growth, innovation, and leadership, and you will work alongside some of the brightest minds in the industry.

Innovative Careers

Stryker offers a range of job opportunities, from internships that provide a stepping stone into high-impact roles to leadership positions that drive strategic direction. Our team members benefit from a work environment that supports professional growth and diversity training, ensuring everyone, regardless of background, can thrive.

Be Part of a Great Team

Our employees enjoy a collaborative atmosphere that fosters innovation and encourages professional development. With a commitment to leadership and diversity, Stryker ensures that all team members have the opportunity to grow and influence the company's future. Our global scale and dedication to impactful solutions make us leaders in medical technology.

Future-Proof Your Career

Stryker is dedicated to career development, offering extensive training, benefits, and resources to help you advance professionally. From networking opportunities to workshops on resume and interview skills, we support your journey every step of the way. Our career paths are as diverse as the innovative products we develop and the markets we serve.

Explore Job Opportunities

Whether you’re just starting out or looking to take your career to the next level, Stryker provides the tools and resources to achieve your goals. We are continuously hiring and looking for ambitious, curious, and driven individuals to join our team.

Stryker Corporation – A Leader in Medical Technology

Our commitment to improving healthcare through innovative products sets us apart in the medical technology field. The synergy of our team’s expertise and our leadership in technology solutions enables us to meet the needs of our customers effectively.

Stay Connected

Join Our Team Search open positions that match your skills and interest. We look for passionate, creative, and solution-driven team players. Explore the many benefits of employment at Stryker, a company that values innovation and leadership.

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Stryker Corporation – Where Talent Meets Opportunity

At Stryker, we believe in turning the challenges of today into the breakthroughs of tomorrow. Join us in our mission to improve healthcare around the world.
Learn more about Stryker Corporation
Size
46,000 employees
Market Cap
$91.9 billion
Industry
Healthcare
Net Income
$1.5 billion
Founded
2004
5 Year Trend
+8.6%
Revenue
$14.3 billion
NASDAQ
SYK
* Ladders Estimates

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