Job Title: Regulatory Project Manager
Location: Irving, TX (100% On-site)
Rate: $40 – $45/hr (W2 only)
Contract Duration: 6 Months (with possible extensions)
Contract Type: W2 (Must be authorized to work in the U.S. — No C2C or visa sponsorships)
We are seeking a Regulatory Project Manager to support regulatory initiatives for a medical products organization. This is an individual contributor role that will provide regulatory support across product lifecycle planning, registration, compliance, and change control. The ideal candidate will have 2–3 years of experience in a regulated industry , preferably in Regulatory Affairs, and a Bachelor’s degree in a science, medical, or technical discipline .
Assist with global product registration and documentation preparation.
Provide regulatory input into product lifecycle planning and change controls.
Develop and update regulatory strategies aligned with evolving requirements.
Prepare and review regulatory submissions for authorities and maintain required licenses and listings.
Evaluate changes for preclinical, clinical, and manufacturing strategies.
Support compliance with post-marketing approval requirements.
Contribute to advertising/promotional material reviews for regulatory compliance.
Maintain awareness of product safety events and participate in recall or safety communication processes.
Assist in risk/benefit analyses and regulatory impact assessments.
Lead or participate in internal regulatory projects and support cross-functional teams.
Bachelor’s Degree in a scientific, engineering, or medical discipline (e.g., biology, chemistry, microbiology, medical technology, pharmacy).
2–3 years of experience in a regulated industry (medical products, pharmaceuticals, nutrition, etc.).
Knowledge of:
Regulatory submission requirements (domestic/international)
GxPs (GCP, GLP, GMP)
Regulatory guidelines and processes
Labeling, promotion, and advertising standards
Experience drafting and editing technical documents
Strong verbal and written communication skills
Excellent attention to detail and ability to track complex information
Project planning and time management skills
Previous experience specifically in Regulatory Affairs
Familiarity with FDA and international regulatory structures
Certification (e.g., RAC – Regulatory Affairs Certification)
Background in quality assurance, R&D, scientific affairs, or operations also considered
Regulatory documentation & submissions
Project management & timeline coordination
Cross-functional collaboration
Attention to detail
Communication & stakeholder engagement
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