Regulatory Compliance Analyst

We are seeking a proactive and detail-oriented Compliance Analyst to lead regulatory compliance efforts across six active medical device testing sites. This role was organically formed in response to a rapid shift from a user study model to a clinic-type study, requiring elevated compliance oversight. The analyst will be instrumental in developing and managing processes that ensure daily regulatory alignment across all sites.

Responsibilities

• Daily Compliance Oversight

• Monitor and ensure timely updates of device logs, participant documentation, and training records.

• Track wearable medical device check-ins and asset management across all sites.

• Confirm staff training compliance and maintain updated training logs.

• Oversee daily data entry into Electronic Data Capture (EDC) systems and flag inconsistencies or delays.

• Identify lagging sites and support them in achieving consistent compliance.

• Process Development & Documentation

• Architect simple, scalable compliance workflows and checklists.

• Establish clear touchpoints and timelines for documentation updates.

• Collaborate with site leads to implement new compliance processes quickly and efficiently.

• Audit & Regulatory Readiness

• Ensure readiness for audits related to SOX compliance and clinical documentation standards.

• Maintain documentation to support sponsor requirements and regulatory expectations.

• Stakeholder Coordination

• Serve as the primary compliance liaison between site leads and sponsor teams.

• Participate in sponsor calls to provide compliance updates and insights.

• Coordinate across sites in Tampa, Boston, Detroit, Phoenix, and the West Coast.

Qualifications

• Experience managing compliance in clinical or medical device environments.

• Familiarity with wearable medical device protocols and EDC systems.

• Strong understanding of SOX compliance and audit documentation.

• Proven ability to develop and implement compliance processes across multiple locations.

• Excellent communication and coordination skills, especially in remote settings.

• Comfortable working independently and managing multiple priorities.

Work Environment

• 100% remote

• Must be able to work within a consistent time zone (Eastern or Pacific preferred)

• Flexible hours with a weekly commitment of 35–40 hours