Stryker Corporation

Staff Regulatory Affairs Specialist (Remote)

Stryker Corporation$95K — $159K *
US-AnywhereRemote in Fremont, CA
Healthcare
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's Degree (B.S. or B.A.)
  • Minimum 4 years of experience in an FDA-regulated industry
  • Minimum 2 years of experience in regulatory affairs
  • Demonstrated knowledge of FDA and international medical device regulations/standards (e.g. EU MDR)
  • Regulatory Affairs Certification (RAC) preferred but not required.

Responsibilities

  • Develop and execute regulatory strategies for pre-market products globally.
  • Evaluate regulatory requirements and identify submission pathways.
  • Author and submit regulatory documents for product approvals.
  • Assess global regulatory impact of product changes and coordinate notifications.
  • Partner with cross-functional teams for regulatory agency interactions.
  • Monitor regulatory intelligence and update strategies as needed.
  • Maintain and update standard operating procedures for compliance.

Benefits

  • Work remotely from anywhere in the United States.
  • Opportunity to work with cutting-edge neurovascular devices.
  • Participation in cross-functional teams to enhance collaboration.
  • Exposure to major global regulatory markets including US and EU.
  • Ability to influence regulatory practices and procedures.
Full Job Description
Work Flexibility: Remote

We are currently seeking a Staff Regulatory Affairs Specialist to join our Neurovascular division. This position is based remotely anywhere in the United States.

As the Staff Regulatory Affairs Specialist, you will support Stryker's neurovascular devices. You will work to bring new medical devices to the market while ensuring ongoing compliance. You will participate on cross-functional teams, develop global regulatory strategies, author regulatory submissions, and interact with regulatory agencies/notified bodies in major markets including the US, EU, Canada, Japan, China, Australia, Brazil, and more.

What you will do
  • Develop and execute regulatory strategies for pre-market products to achieve market access across global regions.
  • Evaluate regulatory requirements and identify submission pathways for new products, ensuring alignment with applicable regulations.
  • Author and submit regulatory documents, including FDA submissions and international dossiers, to support product approvals.
  • Assess global regulatory impact of product or process changes and coordinate required notifications or submissions.
  • Partner with cross-functional teams to support regulatory agency interactions, including responses, meetings, and documentation.
  • Monitor regulatory intelligence and implement updates to strategies based on evolving global requirements.
  • Maintain and update standard operating procedures to ensure compliance and improve regulatory processes.
  • Provide regulatory guidance to stakeholders to align product lifecycle activities with applicable standards.


What you need

Required
  • Bachelor's Degree (B.S. or B.A.)
  • Minimum 4 years of experience in an FDA-regulated industry
  • Minimum 2 years of experience in regulatory affairs
  • Demonstrated applied knowledge of FDA and international medical device regulations/standards (e.g. EU MDR)


Preferred
  • Bachelor's degree in engineering, science, or related field
  • Regulatory Affairs Certification (RAC) or advanced degree in regulatory affairs or related discipline
  • Experience with Class II or Class III medical devices
  • Experience authoring 510(k) submissions or equivalent regulatory filings
  • Experience interacting with regulatory agencies or supporting regulatory meetings


United States of America Pay Ranges:
  • Puerto Rico: $77,700 - $129,500 USD Annual
  • USN: $95,700 - $159,500 USD Annual
  • US5: $100,500 - $167,500 USD Annual
  • US10: $105,300 - $175,500 USD Annual
  • US15: $110,100 - $183,400 USD Annual
  • US20: $114,800 - $191,400 USD Annual
  • US30: $124,400 - $207,400 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.

Travel Percentage: 20%

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

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Learn more about Stryker Corporation
Size
46,000 employees
Market Cap
$91.9 billion
Industry
Net Income
$1.5 billion
Founded
2004
5 Year Trend
+8.6%
Revenue
$14.3 billion
NASDAQ

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