Stryker Corporation

Staff Specialist, Regulatory Affairs

Stryker Corporation$95K — $159K *
Healthcare
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Science, or a related field required
  • Minimum 4 years of regulatory affairs experience in a regulated industry
  • Experience within the medical device industry
  • Master's degree in Regulatory Science or related discipline preferred
  • Regulatory Affairs Certification (RAC) preferred
  • Knowledge of 510(k) and/or CE marking pathways desired
  • Experience with regulatory filings for FDA, EU, or international submissions

Responsibilities

  • Assess regulatory intelligence and update strategies based on evolving requirements
  • Evaluate the regulatory environment and provide guidance across product lifecycle phases
  • Determine product classification, submission requirements, and approval pathways
  • Prepare and submit regulatory filings in accordance with global regulations
  • Identify regulatory risks and propose mitigation strategies
  • Provide guidance on quality, preclinical, and clinical documentation for compliance
  • Communicate with regulatory authorities regarding submissions and review processes

Benefits

  • Work flexibility: Remote, Hybrid, or Onsite options
  • Opportunities for professional development and training
  • Engagement in innovative product development
  • Contribute to impactful healthcare solutions
  • Collaboration with cross-functional teams in a dynamic environment
Full Job Description
Work Flexibility: Remote or Hybrid or Onsite

Stryker is hiring a Staff Regulatory Affairs Specialist in Mahwah, NJ to support new product development for our Joint Replacement implant and instrument portfolio across U.S and international markets This role focuses on developing regulatory strategies, guiding product development teams, and preparing submissions to achieve market access across U.S. and international markets.

What you will do
  • Assess regulatory intelligence and update local, regional, and global regulatory strategies based on evolving requirements
  • Evaluate the regulatory environment and provide guidance across product lifecycle phases including development, manufacturing, and commercialization
  • Determine product classification, submission requirements, and approval pathways across domestic and international markets
  • Prepare and submit regulatory filings in accordance with applicable global regulations and timelines
  • Identify regulatory risks and obstacles, propose mitigation strategies, and recommend refinements based on regulatory outcomes
  • Provide regulatory guidance on quality, preclinical, and clinical documentation to ensure submission readiness and compliance
  • Communicate with regulatory authorities to support submissions, monitor review progress, and respond to agency requests
  • Develop or update regulatory procedures and train cross-functional stakeholders to maintain compliance across the organization


What you will need

Required Qualifications
  • Bachelor's degree required. Preferred to be in Engineering, Science, or a related field
  • Minimum 4 years of experience in regulatory affairs within a regulated industry
  • Experience within the medical device industry


Preferred Qualifications
  • Master's degree in Regulatory Science or related discipline
  • Regulatory Affairs Certification (RAC)
  • Knowledge of 510(k) and/or CE marking pathways
  • Experience preparing and submitting regulatory filings (e.g., FDA, EU, or international submissions)
  • Experience supporting product lifecycle regulatory activities (development through post-market)


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

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