Top 6 Regulatory affairs specialist Jobs in Paramus Nj

Staff Specialist, Regulatory Affairs
Stryker —Mahwah, NJ
- $77,700 - $191,400 a year
- Full-time
- Mid-level
- Office
- Master's degree
- Health savings account
- AD&D insurance
Senior Specialist, Regulatory Affairs
ImmunityBio —Summit, NJ
- $135,000 - $150,000 a year
- Full-time
- 5 years
- Office
- Master's degree
- AD&D insurance
- Disability insurance
Senior Regulatory Affairs Specialist
Flora Food Group —New York, NY
- $105,000 - $135,000 a year
- Office
- Master's degree
- Continuous improvement
Quick Apply
7d
Senior International Regulatory Affairs Specialist
Butterfly Network —New York, NY
- $110,000 - $115,000 a year
- Hybrid work
- 7 years
- English
- Office
- Health savings account
- Employee stock purchase plan
Quick Apply

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Staff Specialist, Regulatory Affairs

Stryker -
Mahwah, NJ

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Job Details

Full-time
$77,700 - $191,400 a year

Benefits

Health savings account
AD&D insurance
Employee stock purchase plan
Paid holidays
Disability insurance
Health insurance
Dental insurance
401(k)
Flexible spending account
Vision insurance
Prescription drug insurance

Qualifications

FDA submissions
Clinical compliance checks
Implementing healthcare compliance training programs
Mid-level
Risk mitigation strategy implementation
Master's degree
Bachelor's degree in engineering
Regulatory submission editing and review
Biomedical regulatory compliance
Communication with regulatory authorities for clinical trials
Clinical quality assurance standards
Training
4 years
Cross-functional collaboration
Cross-functional communication

Full Job Description

Why join Stryker?

Looking for a place that values your unique talents? Discover Stryker's award-winning culture.
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.

Job description

We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! 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.

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. 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.

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regulatory affairs specialist jobs in paramus nj

Staff Specialist, Regulatory Affairs

Senior Specialist, Regulatory Affairs

Senior Regulatory Affairs Specialist

Senior International Regulatory Affairs Specialist

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