Top 55 Regulatory affairs manager Jobs in Edison, Nj

Regulatory & Clinical Affairs Manager
PEAK Technical Services Inc. —Princeton, NJ
- $150,000 - $185,000 a year
- 5 years
- Engineering
- Senior level
- Health insurance
- Dental insurance
Quick Apply
Regulatory and Clinical Affairs Specialist
EDDA TECHNOLOGY, INC. —Princeton, NJ
- $140,000 - $190,000 a year
- Full-time
- 5 years
- Engineering
- Office
- Health insurance
- Dental insurance
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Manager, Regulatory Affairs - Tactical Implementation
Insmed Incorporated —Bridgewater, NJ
- $133,000 - $173,000 a year
- Full-time
- Remote
- Microsoft Outlook
- 5 years
- Bachelor's degree
- Employee stock purchase plan
- Disability insurance
Associate Manager, Regulatory Affairs
Exeltis & Xiromed —Florham Park, NJ
- Full-time
- Hybrid work
- Microsoft Excel
- Microsoft Outlook
- Writing skills
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14d
Regulatory Affairs Manager
TRIPLECOM —New Brunswick, NJ
- Office
- 3 years
- Bachelor's degree
Manager/Director of Government and Regulatory Affairs
New Jersey Utilities Association —Freehold, NJ
- Weekends as needed
- Hybrid work
- 7 years
- Office
- Master's degree
- Health insurance
- 401(k)
Quick Apply
Manager Regulatory Affairs
Breckenridge Pharmaceutical Inc —Berkeley Heights, NJ
- $120,000 - $165,000 a year
- Full-time
- 8 years
- Analysis skills
- Bachelor's degree
- Health insurance
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Regulatory Affairs Project Manager (173814)
Colgate-Palmolive —Piscataway, NJ
- $124,000 - $174,000 a year
- Hybrid work
- Master's degree
- Bachelor's degree
- Travel
- Profit sharing
- Paid parental leave
US Regulatory Affairs Senior Manager – Allergy
Opella Healthcare Group —Morristown, NJ
- $127,500.00 - $184,166.66 a year
- Full-time
- Hybrid work
- Bachelor's degree
- Doctor of Philosophy
- Mentoring
Regulatory Affairs Project Manager
Roche —Branchburg, NJ
- $93,000 - $172,900 a year
- Online Application
- Hybrid work
- 5 years
- Master's degree
- Bachelor's degree
3d
Manager, Regulatory Affairs - China
Fresh —Jersey City, NJ
- $100,000 - $140,000 a year
- Full-time
- Office
- Master's degree
- Bachelor's degree
- Commuter assistance
- Paid parental leave
Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Therapeutic Neurotoxins - Hybrid
AbbVie —Florham Park, NJ
- $124,500 - $236,500 a year
- 8 hour shift
- Hybrid work
- Doctor of Philosophy
- Experience equivalent to degree accepted
- Senior level
- Paid holidays
- Health insurance
Regulatory Affairs Program Manager
ImmunityBio —Summit, NJ
- $141,300 - $157,000 a year
- Full-time
- Office
- Analysis skills
- Bachelor's degree
- AD&D insurance
- Disability insurance
Project Manager, Regulatory Affairs - Project Management
Aleon Pharma International, Inc. —Parsippany-Troy Hills, NJ
- $70,000 - $80,000 a year
- Email
- Hybrid work
- 11+ years
- Mid-level
- US work authorization
- Health insurance
- Dental insurance
Quick Apply
Manager, Regulatory Affairs - Cosmetics (Global)
Church & Dwight —Princeton, NJ
- $110,900 - $157,900 a year
- Full-time
- 8 years
- Senior level
- Leadership
- Profit sharing
- Paid parental leave
Manager, Regulatory Affairs
MTF Biologics —Edison, NJ
- $125,000 a year
- Full-time
- Management
- 5 years
- Bachelor's degree
Quick Apply
Senior Regulatory Affairs & Quality Systems Manager - IVD / FDA 510(k)
Essenlix —Monmouth Junction, NJ
- Full-time
- 5 years
- Bachelor's degree
- Senior level
- Health insurance
- 401(k)
Quick Apply
Manager-CMC Manager- Regulatory Affairs
Genpact —Jersey City, NJ
- Temporary
- Senior level
- Leadership
- Communication skills
Manager, Project Management, Regulatory
Legend Biotech US —Somerset, NJ
- $110,706 - $145,303 a year
- Full-time
- Microsoft Excel
- Mid-level
- Master's degree
Quick Apply
Senior Regulatory Affairs Specialist
OrganOx —Madison, NJ
- $120,000 - $137,000 a year
- Full-time
- Hybrid work
- 5 years
- Continuous improvement
- Travel
- Paid holidays
- Disability insurance
Quick Apply

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Regulatory & Clinical Affairs Manager

PEAK Technical Services Inc. -
Princeton, NJ

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Job Details

$150,000 - $185,000 a year

Benefits

Health insurance
Dental insurance
401(k)
Flexible spending account
Vision insurance
Paid sick time

Qualifications

FDA submissions
Medical writing
Content creation for technical audiences
Technical documentation
Collaboration with product development teams
Regulatory submission editing and review
Biomedical regulatory compliance
Communication with regulatory authorities for clinical trials
Technical project management
IRB compliance
Medical imaging
Technical writing experience within technology
Ethical review application preparation
ISO 13485

Full Job Description

#Eng-IT-01

Position Summary

Our client is seeking a hands-on professional to support the full regulatory lifecycle for innovative AI-enabled medical device software. This individual will prepare and execute FDA, EU MDR, and international regulatory submissions while partnering closely with engineering, quality, and clinical teams throughout product development.

Responsibilities

Regulatory Affairs

Prepare, author, and execute FDA 510(k), software modification, and international regulatory submissions.
Develop regulatory strategies for new products, software updates, and design changes.
Assess regulatory impacts related to AI/ML software, cybersecurity, risk management, verification, and validation activities.
Prepare and maintain EU MDR Technical Documentation and support CE Mark submissions.
Interface directly with FDA, notified bodies, and international regulatory agencies.
Collaborate with engineering teams to ensure regulatory requirements are incorporated throughout product development.
Monitor evolving regulatory requirements and communicate business impacts.

Clinical Affairs

Support preparation of IRB applications, clinical protocols, investigator documentation, study reports, and publications.
Coordinate clinical collaborations with hospitals, physician investigators, and research partners.
Assist with clinical evidence generation supporting regulatory submissions and product validation.
Manage multiple regulatory and clinical projects while maintaining schedules and deliverables.

Qualifications

Required

Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, or a related discipline.
5–10 years of medical device regulatory affairs experience.
Demonstrated hands-on experience preparing and submitting FDA 510(k) submissions.
Experience preparing EU MDR Technical Documentation and CE Mark submissions.
Experience supporting Software as a Medical Device (SaMD), AI/ML-enabled medical devices, medical imaging, digital health, robotics, or surgical navigation products.
Experience working directly with engineering teams throughout the product development lifecycle.
Strong technical writing and project management skills.
Knowledge of ISO 13485, ISO 14971, and IEC 62304.

Preferred

Clinical affairs experience including IRB submissions, clinical studies, or hospital-based research collaborations.
Experience interacting directly with FDA reviewers, notified bodies, and clinical investigators.

Benefits
PEAK's benefit offerings available for our associates include medical, dental, vision, Flexible Spending Account (FSA), Dependent Care Savings Account (DCA), and 401K plan. PEAK believes that taking care of our team is essential for success and we are proud to provide benefits that enhance both your well-being and your future. Additionally, our associates may be eligible for Paid Sick Leave as required by Federal, State, or local laws.

Equal Opportunity Employer (EEO)
PEAK Technical Staffing is committed to creating a diverse and inclusive environment and is proud to be an Equal Opportunity Employer. PEAK does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status, or any other characteristic protected by applicable law. All employment decisions are made based on qualifications, merit, and business need. We encourage all individuals to apply.

Americans Disabilities Act (ADA)
The physical and mental requirements described in this job description are representative of those that must be met by an employee to successfully perform the essential functions of the position. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. Must be able to perform the essential physical functions of the position, including sitting, standing, walking, stooping, kneeling, and lifting up to 25 pounds, with or without reasonable accommodation.

Candidate Privacy
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://peaktechnical.com/privacy-policy/ and https://peaktechnical.com/ca-residents-privacy-rights/

AI Recruiting Disclosure
We use AI-assisted tools to help review applications and compare your experience to job requirements, but all hiring decisions are made by human recruiters. You may request a human-only process or opt out of automated communication at any time. Required notices and our latest bias audit are available on our website: www.peaktechnical.com/ai-disclosure.

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Refine Your Search

regulatory affairs manager jobs in edison, nj

Regulatory & Clinical Affairs Manager

Regulatory and Clinical Affairs Specialist

Manager, Regulatory Affairs - Tactical Implementation

Associate Manager, Regulatory Affairs

Regulatory Affairs Manager

Manager/Director of Government and Regulatory Affairs

Manager Regulatory Affairs

Regulatory Affairs Project Manager (173814)

US Regulatory Affairs Senior Manager – Allergy

Regulatory Affairs Project Manager

Manager, Regulatory Affairs - China

Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Therapeutic Neurotoxins - Hybrid

Regulatory Affairs Program Manager

Project Manager, Regulatory Affairs - Project Management

Manager, Regulatory Affairs - Cosmetics (Global)

Manager, Regulatory Affairs

Senior Regulatory Affairs & Quality Systems Manager - IVD / FDA 510(k)

Manager-CMC Manager- Regulatory Affairs

Manager, Project Management, Regulatory

Senior Regulatory Affairs Specialist

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#Eng-IT-01

Position Summary

Responsibilities

Regulatory Affairs

Clinical Affairs

Qualifications

Required

Preferred

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regulatory affairs manager jobs in edison, nj

I want to receive the latest job alert for regulatory affairs manager in edison, nj

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#Eng-IT-01 Position Summary

Responsibilities

Regulatory Affairs

Clinical Affairs

Qualifications

Required

Preferred

#Eng-IT-01

Position Summary