Staff Specialist, Regulatory Affairs
Summary
Staff Regulatory Affairs Specialist in Mahwah, NJ develops regulatory strategies for medical device product development, prepares submissions for U.S. and international markets, and guides teams through compliance processes.
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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