Staff Regulatory Affairs Specialist

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.

What You Will Do

• 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

What You Will Need

Required Qualifications:

• 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

Preferred Qualifications:

• 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

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

View the U.S. work location and transparency guide to find the pay range for your location.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.