Staff Regulatory Affairs Specialist

Stryker•Mahwah, NJ

1d•$114,800 - $191,400•Hybrid

About The Position

Stryker is hiring a Staff Regulatory Affairs Specialist in Mahwah, NJ to ensure continued market access and regulatory compliance for its Joint Replacement implant and instrument portfolio across U.S. and international markets. This role focuses on maintaining compliance for marketed products, evaluating regulatory changes, and supporting product lifecycle activities. You will work across functions and geographies to ensure submissions, labeling, and processes align with current regulatory requirements.

Requirements

Bachelor’s degree required; strongly preferred in Engineering, Science, or a related technical field
4+ years of experience in an FDA-regulated environment, specifically within medical devices or pharmaceutical industries

Nice To Haves

RAC certification or Master’s degree in Regulatory Affairs or related field
Experience supporting Class II and/or Class III medical device products
Experience preparing regulatory submissions (e.g., 510(k), technical files)
Knowledge of medical device product development and design control processes
Ability to proactively communicate, escalate risks appropriately, and engage leadership when needed

Responsibilities

Maintain regulatory compliance for marketed medical devices across U.S. and international markets
Monitor and evaluate changes in global medical device regulations, with a strong focus on EU MDR, and implement required updates to maintain market access
Prepare and submit regulatory submissions in alignment with regional and global requirements
Assess the regulatory impact of product, process, or labeling changes and support required notifications or submissions
Review product labeling and promotional materials to ensure alignment with regulatory standards
Develop and update standard operating procedures and implement process improvements to support regulatory compliance
Provide regulatory guidance to internal stakeholders and deliver training on current and evolving requirements
Partner with global affiliates to support product registrations and maintain accurate regulatory documentation