Arbour Group is a leading provider of regulatory products and services for the pharmaceutical, medical device, and biotechnology industries. We provide business risk management to our clients by assisting with regulatory software compliance in areas such as risk assessment, quality policy/ITSOP development, software validation, regulatory system migration, process control validation, I.T. platform qualification, compliance training, and outsourcing.

Arbour Group is headquartered in Chicago, IL, with offices also in California, New Jersey, and North Carolina. Additionally, we have international offices in Dubai, U.A.E, and Manila, Philippines.

The Arbour Advantage lies in our combination of service offerings that are designed to help multinational companies harmonize compliance efforts across diverse system platforms, geographically dispersed facilities, and complex regulatory environments. Our results-oriented, client-tailored approach has successfully helped numerous companies achieve compliance with domestic and international authorities quickly and cost-effectively. To learn more about Arbour Group, visit our website at www.arbourgroup.com.

Job Summary:

The Compliance Manager is responsible for executing projects within the timelines and budget and providing guidance to the project team. The candidate should be able to gather and prioritize client requirements, communicate clearly, and deliver high-quality work products. The Compliance Manager must have excellent knowledge of the Life Sciences industry and related regulations.

The role provides direction to multiple, complex, technically oriented projects to ensure compliance to applicable regulations and quality management related to computer systems, applications, and software medical devices (SaMD, MDDS, etc.). Must be able to independently plan, organize, and control the activities of multiple project teams.

Responsibilities:

• Conduct discussions with clients to ensure requirements and objectives from a compliance standpoint are clearly understood.
• Communicate regulatory requirements to clients in a convincing manner and explain compliance gaps.
• Provide oversight and guidance to project staff, review the project team's work, and ensure the quality of deliverables.
• Ensure that the projects are well tracked and ensure timeliness and budget discipline.
• Track and analyze regulatory changes and updates to the Life Sciences industry and stay current.

• Perform other job-related duties as assigned.

Required Skills:

• About 8 years of total experience, out of which at least 3 years are in a manager role.
• Knowledge of Life Sciences industry regulations (FDA, EMA, etc.) and best practices (ISO, GAMP, etc.), including but not limited to quality management of:
  • Traditional Computer Systems
  • Cloud and SaaS
  • Software Medical Devices (SaMD, MDDS)
  • Digital Health solutions
• Experience in leading large validation/CSV projects end to end, including ERP systems, SaaS solutions, infrastructure, and databases.
• Experience with Agile/DevOps SDLC processes.
• Familiarity with the regulatory pathway and ability to process 510K submissions for Software devices.
• Knowledge and experience working in compliance with privacy regulations (GDPR, HIPAA, CCPA, etc.) is a plus.
• Previous experience with Big 4 Consulting firms is preferred.