Staff Specialist, Regulatory Affairs

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)

US20 : $114,800 - $191,400 USD Annual

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