Regulatory Affairs Specialist

Base pay range

$120.00/hr - $140.00/hr

Role

PMA Contractor Support – Regulatory Affairs (IVD Medical Devices)

Location

Secaucus, NJ 07094 (Remote)

Shift Schedule

Monday–Friday, day shift (8:00 AM – 5:00 PM)

Remote Candidate

Candidate can be remote in the US but West Coast is preferred for PST time zone.

Hours per Week

40 hours

Start Date

ASAP

Pay Highlights

$120-140/hour (Based on years of experience)

Key Responsibilities

• Author, draft, compile, and submit all modules of an IVD PMA submission
• Ensure PMA documentation aligns with FDA regulatory standards and expectations
• Support regulatory strategy execution for PMA activities throughout the project lifecycle
• Contribute to timely and high-quality submission deliverables

Cross‑Functional Collaboration

• Work closely with internal stakeholders across R&D, Quality, Clinical, and other functional teams
• Gather technical, clinical, and validation information required for PMA documentation
• Facilitate collaboration to resolve submission‑related questions or gaps

Project Execution & Compliance

• Manage assigned regulatory deliverables with minimal supervision
• Maintain compliance with internal processes and FDA regulatory requirements
• Support ongoing updates, revisions, or responses related to PMA documentation as needed

Qualifications

Education: Bachelor’s degree in a scientific, engineering, or related discipline —
Required

• Minimum 5 years of direct PMA regulatory experience —
  Required
• Proven, hands‑on experience authoring and submitting full PMA modules for IVD medical devices
• Prior experience with tissue‑based IVD products —
  Strongly Preferred

Equal Employment Opportunity Statement

As a certified minority‑owned business, Pride Global and its affiliates — including Russell Tobin, Pride Health, and Pride Now — are committed to creating a diverse environment and are proud to be an equal‑opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or other characteristics.

Seniority

level

Not Applicable

Employment type

Contract

Job function

Health Care Provider

Industries:
Staffing and Recruiting

About Pride Health

Pride Health is Pride Global's healthcare staffing branch, providing recruitment solutions for healthcare professionals and the industry at large since 2010.

As a minority‑owned business that delivers exceptional service to its clients and candidates by capitalizing on diverse recruiting, account management, and staffing backgrounds, Pride Health's expert team provides tailored and swift sourcing solutions to help connect healthcare talent with their dream jobs. Our personalized approach within the industry shines through as we continue cultivating honest and open relationships with our network of healthcare professionals, creating an unparalleled environment of trust and loyalty.

Benefits

Pride Global offers eligible employees comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance, and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, auto, home insurance, pet insurance, and employee discounts.

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