Staff Specialist, Regulatory Affairs

Work Flexibility: Hybrid or Onsite

Stryker is hiring a Staff Regulatory Affairs Specialist in Mahwah, NJ to support new product development for ourJoint 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)