Compliance & Monitoring Specialist

Job Summary

We are seeking a proactive and detail-oriented Compliance & Monitoring Specialist to join our dynamic team. In this role, you will be instrumental in ensuring our organization adheres to all relevant regulatory standards, including FDA regulations, EMA guidelines, and international quality assurance protocols. Your expertise will support the development, implementation, and oversight of compliance programs across various departments, particularly in areas related to clinical trials, pharmaceutical regulatory compliance, and biomedical regulations. This position offers an exciting opportunity to contribute to high-stakes projects that safeguard health and ensure product integrity while fostering a culture of continuous improvement and regulatory excellence.

Responsibilities

• Develop, review, and maintain comprehensive compliance management systems aligned with FDA regulations, ISO 13485 standards, ICH guidelines, and other applicable health regulation policies.
• Conduct thorough regulatory compliance analysis to identify potential risks and implement effective risk management strategies.
• Oversee regulatory submissions for drug approvals, clinical trial authorizations, and other necessary documentation in accordance with FDA, EMA, and global standards.
• Monitor ongoing compliance projects related to pharmaceutical manufacturing processes, quality assurance procedures, and biomedical regulatory requirements.
• Collaborate cross-functionally with research teams, quality assurance units, regulatory affairs specialists, and project managers to ensure seamless communication and adherence to regulatory standards.
• Utilize compliance management software to track audit findings, corrective actions, and compliance metrics; generate detailed reports for senior management.
• Stay current with evolving health regulation policies, drug regulation updates, and international standards such as ICH guidelines to proactively adapt compliance strategies.

Requirements

• Bachelor’s degree in life sciences, pharmacy, chemistry, or a related field; advanced certifications in regulatory affairs or compliance management are preferred.
• Proven experience working with FDA regulations, clinical trials oversight, or pharmaceutical regulatory compliance within a regulated environment.
• Strong understanding of chemistry, manufacturing & controls (CMC), drug regulation processes, and biomedical regulatory frameworks.
• Demonstrated ability to manage multiple compliance projects simultaneously using compliance management software tools.
• Excellent data analysis skills coupled with meticulous attention to detail for conducting regulatory compliance assessments.
• Knowledge of ISO 13485 standards for medical devices and EMA regulations is highly desirable.
• Exceptional writing skills for preparing clear documentation such as regulatory submissions and audit reports.
• Strong project management capabilities with the ability to coordinate cross-functional teams effectively.

Join us in advancing healthcare safety by ensuring our products meet the highest standards of regulatory compliance! We are committed to fostering an inclusive environment where your expertise makes a meaningful impact on public health worldwide.

Pay: $24.35 - $29.32 per hour

Expected hours: 40.0 per week

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Health insurance
• Paid parental leave
• Paid time off
• Parental leave
• Professional development assistance
• Tuition reimbursement

Work Location: Hybrid remote in Knoxville, TN 37902

Salary : $24 - $29