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

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.