Job Description

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)

Position Overview:

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 .

Key Responsibilities:

• 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.

Required Qualifications:

• 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

Preferred Qualifications:

• 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

Top Skills:

• Regulatory documentation & submissions

• Project management & timeline coordination

• Cross-functional collaboration

• Attention to detail

• Communication & stakeholder engagement

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