Clinical Compliance Manager

Custom Search Inc.; Minneapolis (MN); On-site; USD 110,000 - 150,000; Full time

Job summary

Top Echelon Software, LLC is partnering with a growing medical device company to hire a Clinical Compliance Manager. The role focuses on audits, regulatory alignment, and maintaining TMF and documentation controls within a fast-paced setting in Minneapolis.

The ideal candidate has a life sciences background with 5+ years in clinical compliance or quality assurance, strong knowledge of FDA/ISO/GCP requirements, and hands-on experience with eQMS and CAPA processes.

Qualifications

• Bachelor's degree in Life Sciences, Regulatory Affairs, Healthcare, or related field.
• 5+ years of clinical compliance, clinical operations, or quality assurance in med devices/pharma/biotech.
• Experience supporting clinical trials and regulatory inspections/audits.
• Strong knowledge of FDA regulations, ISO 14155, ISO 13485, EU MDR, and GCP.
• Experience with audit management, CAPAs, document control, and electronic quality management systems (eQMS).
• Familiarity with TMF oversight, clinical documentation, and vendor compliance.

Responsibilities

• Lead coordination and preparation for internal/external audits, FDA inspections, notified body assessments, and quality system audits.
• Maintain audit readiness by reviewing clinical docs, processes, and records for accuracy and compliance.
• Partner with Clinical, Quality, and Regulatory teams to ensure compliance with FDA, ISO, EU MDR, and GCP requirements.
• Identify compliance gaps, manage audit findings, and track CAPAs through resolution.
• Develop and improve clinical compliance procedures, SOPs, documentation controls, and training processes.
• Support TMF oversight, clinical site documentation, vendor qualifications, and training records.
• Monitor compliance risks, communicate findings to leadership, and propose improvements as the organization grows.

Skills

Audit coordination

Regulatory compliance

Documentation control

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences or related field

Tools

eQMS

TMF oversight

CAPA management

Job description

We are partnering with a growing medical device company developing next-generation cardiovascular technology. As the company advances its pivotal clinical trials and prepares for commercialization, they are adding a Clinical Compliance Manager to help ensure clinical operations remain compliant, audit-ready, and aligned with regulatory requirements.

This is a great opportunity for someone who enjoys hands-on compliance work, identifies gaps, improves processes, and takes ownership of initiatives. You'll work closely with Clinical, Quality, and Regulatory teams in a startup environment where your expertise and contributions will have a direct impact.

Your Role with the Company:

• Lead the coordination and preparation for internal and external audits, FDA inspections, notified body assessments, and quality system audits.

• Maintain ongoing audit readiness by reviewing clinical documentation, processes, and records for accuracy, completeness, and compliance.

• Partner with Clinical, Quality, and Regulatory teams to ensure compliance with FDA regulations, ISO 14155, ISO 13485, EU MDR, and GCP requirements.

• Identify compliance gaps, manage audit findings, and track corrective actions and CAPAs through resolution.

• Develop and improve clinical compliance procedures, SOPs, documentation controls, and training processes.

• Support Trial Master File (TMF) oversight, clinical site documentation, vendor qualifications, and training records.

• Monitor compliance risks, communicate findings to leadership, and recommend improvements as the organization grows.

Desired Profile:

• Bachelor's degree in Life Sciences, Quality, Regulatory Affairs, Healthcare, or a related field.

• 5+ years of experience in clinical compliance, clinical operations, or quality assurance within the medical device, pharmaceutical, or biotechnology industry.

• Experience supporting clinical trials and preparing for or participating in regulatory inspections and audits.

• Strong understanding of FDA regulations, ISO 14155, ISO 13485, EU MDR, and Good Clinical Practice (GCP).

• Experience with audit management, CAPAs, document control, and electronic quality management systems (eQMS).

• Familiarity with TMF oversight, clinical documentation, and vendor compliance.

• Experience in a medical device startup or growing organization is highly desirable.

• Strong organizational and communication skills with the ability to work independently, collaborate across teams, and drive initiatives forward.