Manager Regulatory Affair at Capgemini Engineering coordinating activities for the US market. Preparing submissions to the FDA and collaborating with internal teams for regulatory compliance.
About the role
- Compliance Coordinator supporting Healthcare Compliance initiatives at EXL. Ensuring compliance with ethical, legal, and regulatory requirements.
Responsibilities
- Assist in employee awareness with regards to their responsibilities and the company's obligations to maintain ethical work practices and complying with all applicable laws and regulations
- Consistently review and develop compliance materials and implement same, as required.
- Support compliance initiatives including but not limited to incident management.
- Liaise with various stakeholders globally to ensure on-time delivery of all projects
- Evaluate current procedures/controls for efficiency and accuracy. Recommend solutions for process improvement as appropriate
- Prepare compliance reports for leadership and committees, including metrics, outcomes, and corrective actions.
- Conduct monthly and quarterly audits as needed to ensure compliance with established internal control procedures by examining records, reports, operating practices, and documentation
- Will perform other duties as assigned
Requirements
- High School diploma obtained
- Experience in a role working in the healthcare industry.
- Experience in a role working in or with Compliance
- BS or BA obtained in a related field
- Advanced computer experience and knowledge of Microsoft Office Suite including Excel, Word, Visio, Outlook, and PowerPoint
- Analytical thinker with strong conceptual and problem-solving skills.
- Meticulous attention to detail with the ability to multi-task.
- Ability to work under pressure and meet deadlines.
- Effective communication skills, both verbal and written, to communicate with internal teams as well as clients on incidents
- Ability to take directions, work independently and as part of a team.
Benefits
- For more information on benefits and what we offer please visit us at https://www.exlservice.com/us-careers-and-benefits
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