REGULATORY & CLINICAL AFFAIRS MANAGER

Princeton, NEW JERSEY

JOB

REFERENCE ID

26-01372

JOB TYPE:

Direct Placement

LOCATION

Princeton, NEW JERSEY

PAY RATE:

$150000 - $185000

POST DATE:

August 24, 2026

: #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.