Stryker Corporation

Senior Specialist Regulatory Affairs

Stryker Corporation • $95K — $159K *
Irvine, CA 92620In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or related field.
  • Minimum 2 years of experience in Regulatory Affairs.
  • Experience preparing and reviewing regulatory submissions and documentation.
  • Ability to interpret and apply regulatory requirements in a regulated environment.
  • (Preferred) Master's degree in Regulatory Science or related field.
  • (Preferred) Regulatory Affairs Certification (RAC).
  • (Preferred) Experience with global regulatory submissions and interactions.

Responsibilities

  • Assess regulatory intelligence to support global regulatory strategies.
  • Evaluate products and changes for regulatory classification and compliance impact.
  • Prepare and submit regulatory filings according to global regulations.
  • Monitor regulatory authority review and communicate with agencies during submissions.
  • Provide regulatory guidance to cross-functional teams throughout product development.
  • Review quality and clinical documentation to support compliance and submissions.
  • Identify regulatory risks and recommend solutions to project timelines.

Benefits

  • Work flexibility with hybrid or onsite options.
  • Opportunity to contribute to regulatory strategy and product lifecycle activities.
  • Collaborative work environment with cross-functional teams.
  • Engagement in global regulatory compliance initiatives.
  • Chance to impact the launch of medical technologies to market.
Full Job Description
Work Flexibility: Hybrid or Onsite

Senior International Regulatory Affairs Specialist

Irvine, CA

Join a team focused on bringing medical technologies to market while ensuring compliance with global regulatory requirements. In this role, you will support regulatory strategy, submissions, and product lifecycle activities across a range of projects, partnering with cross-functional teams to navigate regulatory requirements and maintain product compliance in global markets.

This position offers the opportunity to contribute to regulatory planning, agency interactions, and submission activities while collaborating with product development, quality, clinical, and manufacturing teams.

Work Flexibility:
Hybrid: candidates must reside within commuting distance of Irvine, CA and be able to work onsite several days per week.

What You Will Do
  • Assess regulatory intelligence and regulatory requirements to support local, regional, and global regulatory strategies.
  • Evaluate products, product changes, and manufacturing changes for regulatory classification, submission requirements, and compliance impact.
  • Prepare, compile, and submit regulatory submissions and supporting documentation in accordance with applicable global regulations and guidelines.
  • Monitor regulatory authority review activities and support communications with regulatory agencies throughout the submission process.
  • Provide regulatory guidance to cross-functional teams throughout product development, manufacturing, clinical, and post-market activities.
  • Review quality, preclinical, clinical, and manufacturing documentation to support regulatory submissions and compliance requirements.
  • Identify regulatory risks, emerging requirements, and potential market access obstacles, and recommend solutions to support project timelines.


What You Will Need

Required Qualifications
  • Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or a related field.
  • Minimum 2 years of experience in Regulatory Affairs.
  • Experience preparing, reviewing, or supporting regulatory submissions and regulatory documentation.
  • Experience interpreting and applying regulatory requirements within a regulated environment.

Preferred Qualifications
  • Master's degree in Regulatory Science or a related field.
  • Regulatory Affairs Certification (RAC).
  • Experience supporting global regulatory submissions and regulatory authority interactions.
  • Experience working with medical devices or other regulated healthcare products.


  • $95,800 - $159,600 USD Annual


Travel Percentage: 0%

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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