Staff Specialist, Regulatory Affairs

Responsibilities

• 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

Requirements

• 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
• 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%

Benefits

Additional Information

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.

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Company Intel

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