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Regulatory Compliance Manager

Regulatory Compliance Manager

Insight GlobalFarmington, MI, US
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Regulatory Compliance Manager

We are seeking a proactive and detail-oriented Regulatory Compliance Manager to lead compliance efforts for product research involving consumer electronics and "health" tech device studies. The Compliance Manager will play a critical role in developing and managing processes that ensure daily regulatory alignment across all research testing sites. This is an individual contributor role and does not involve managing a team.

Responsibilities :

  • Daily Compliance Oversight - Perform daily clinical and operational compliance checks. Monitor device logs, participant documentation, and training records.
  • Track wearable medical device check-ins and asset management.
  • Confirm staff training compliance and maintain updated logs.
  • Oversee daily data entry into Electronic Data Capture (EDC) systems and flag inconsistencies.
  • Identify lagging sites and support them in achieving consistent compliance.

Process Development & Documentation :

  • Design scalable compliance workflows and checklists.
  • Establish clear touchpoints and timelines for documentation updates.
  • Collaborate with site leads to implement new compliance processes 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 different time zones.

    • We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity / affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and / or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy.

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    Regulatory Compliance Manager • Farmington, MI, US