Stryker Corporation

Staff Regulatory Affairs Specialist, Mako and Enabling Technologies (Remote)

Stryker Corporation • $95K — $159K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Sciences, Regulatory Affairs, or related field.
  • Minimum 4 years of experience in an FDA-regulated industry.
  • At least 3 years of Regulatory Affairs experience.
  • Experience preparing regulatory submissions for product approvals.

Responsibilities

  • Develop and execute global regulatory strategies for new products and lifecycle management.
  • Ensure U.S. and international regulatory requirements are met in product development.
  • Evaluate product classifications and regulatory pathways for medical devices.
  • Author and submit FDA and international regulatory filings and documentation.
  • Review quality and clinical documentation for submission readiness.
  • Partner with global regulatory teams for market expansions and compliance activities.
  • Lead communications with regulatory authorities and review product claims for compliance.

Benefits

  • Work flexibility with a remote position.
  • Preference for candidates in the U.S. Eastern Time Zone.
Full Job Description
Work Flexibility: Remote

Staff Regulatory Affairs Specialist, Mako and Enabling Technologies (Remote)

Join Stryker's Ortho Tech Business and support a portfolio that spans robotics, navigation, imaging, software, and capital equipment technologies. In this role, you will provide regulatory leadership throughout the product lifecycle, partnering with cross-functional teams to support global product development, regulatory submissions, market access, and ongoing regulatory compliance across U.S. and international markets.

Work Flexibility:This is a remote position, with a preference for candidates located in the U.S. Eastern Time Zone

What You Will Do
  • Develop and execute global regulatory strategies for new products, product changes, and lifecycle management activities.
  • Participate in product development teams to ensure U.S., European, and international regulatory requirements are incorporated throughout all development phases.
  • Evaluate product classifications, regulatory pathways, and jurisdictional requirements for medical devices and related technologies.
  • Author and submit regulatory filings, including FDA submissions, international registrations, and supporting documentation required for product approvals.
  • Review quality, preclinical, and clinical documentation to ensure submission readiness and regulatory compliance.
  • Partner with global regulatory affiliates to support registrations, market expansions, and post-market regulatory activities.
  • Lead interactions with regulatory authorities and notified bodies, including preparation of responses, submissions, and agency communications.
  • Review product labeling, marketing materials, and product claims for compliance with applicable regulatory requirements and mentor junior regulatory team members on regulatory processes and best practices.


What You Will Need

Required Qualifications
  • Bachelor's degree in Engineering, Sciences, Regulatory Affairs, or a related field.
  • Minimum 4 years of experience in an FDA-regulated industry.
  • Minimum 3 years of Regulatory Affairs experience.
  • Experience preparing regulatory submissions for product approvals.

Preferred Qualifications
  • Regulatory Affairs Certification (RAC) and/or Master's degree in Regulatory Affairs or a related field.
  • Experience supporting Class II and/or Class III medical devices.
  • Experience authoring FDA 510(k) submissions.
  • Experience interacting directly with regulatory agencies and notified bodies.


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: None

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
Net Income
$1.5 billion
Founded
2004
5 Year Trend
+8.6%
Revenue
$14.3 billion
NASDAQ

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