Sr. Compliance Specialist (Regulated Industry)

Mentor Technical Group seeks a Sr. Compliance Specialist (Regulated Industry) for our Monroe, Union County location. In this full-time position, you'll lead compliance initiatives and regulatory strategy across our portfolio of technical solutions serving the FDA-regulated pharmaceutical, biotechnology, and medical device sectors.

Role Overview

As Senior Compliance Specialist, you'll serve as a strategic regulatory advisor within a dynamic organization renowned for its expertise in life science compliance. Mentor Technical Group supports clients across the FDA-regulated industry, and your role will be central to maintaining and advancing our own compliance posture while supporting clients' regulatory excellence.

Your Responsibilities

• Design, implement, and oversee compliance programs aligned with FDA regulations and GxP standards for pharmaceutical and medical device operations
• Lead regulatory submissions, correspondence, and interactions with FDA and other regulatory bodies
• Develop and maintain standard operating procedures, compliance documentation, and quality assurance frameworks
• Conduct internal audits and compliance assessments to identify gaps and opportunities for improvement
• Provide compliance training and mentorship to team members across the organization
• Evaluate emerging regulatory requirements and implement strategies to ensure ongoing alignment with evolving standards
• Collaborate with cross-functional teams on product development, manufacturing, and quality initiatives from a regulatory perspective

Skills & Qualifications

• Bachelor's degree in life sciences, regulatory affairs, quality assurance, or related field
• Minimum 7+ years of compliance or regulatory affairs experience in FDA-regulated industries (pharmaceutical, biotech, or medical device)
• Deep knowledge of FDA regulations, cGMP, FDA inspection processes, and Good Practices (GxP) frameworks
• Strong written and verbal communication skills with ability to translate complex regulatory concepts for diverse audiences
• Demonstrated expertise in compliance documentation, risk assessment, and regulatory gap analysis
• Detail-oriented mindset with excellent organizational and project management capabilities
• Ability to lead cross-functional initiatives and mentor junior compliance professionals

Why Join Mentor Technical Group

Mentor Technical Group is a recognized leader in life science engineering and technical solutions. Working here means joining a team with deep expertise in FDA compliance and regulatory excellence. You'll influence how we serve clients across the pharmaceutical, biotechnology, and medical device industries while advancing your own regulatory career in a collaborative, impact-driven environment.

Applying for This Role

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