- Mahwah, NJ 07430, United States
- United States
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Why join Stryker?
Looking for a place that values your unique talents? Discover Stryker's award-winning culture. We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more: US Stryker employee benefits
Job description
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)
Posted Date: 06/19/2026 This role will be posted for a minimum of 3 days.
United States of America Pay Ranges:
Puerto Rico: $77,700 - $129,500 USD Annual
USN: $95,700 - $159,500 USD Annual
US5: $100,500 - $167,500 USD Annual
US10: $105,300 - $175,500 USD Annual
US15: $110,100 - $183,400 USD Annual
US20: $114,800 - $191,400 USD Annual
US30: $124,400 - $207,400 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. Click here to learn more about: US Stryker employee benefits Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics 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.
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