[Hiring] Regulatory Coordinator @ELEVATE CLINICAL RESEARCH, INC.

Role Description

The Regulatory Coordinator plays a critical role in ensuring that healthcare and social assistance organizations comply with all applicable federal, state, and local regulations. This position involves:

• Coordinating regulatory submissions and maintaining documentation.
• Facilitating communication between regulatory bodies and internal departments.
• Monitoring changes in legislation and guidelines to proactively update compliance strategies.
• Managing timelines and regulatory requirements to mitigate risks.
• Ensuring the organization operates within legal frameworks, fostering trust and integrity in its operations.

Please note this is a full-time remote position.

Qualifications

• Bachelor’s degree in Health Administration, Public Health, Life Sciences, or a related field.
• At least 2 years of experience in regulatory affairs, healthcare compliance, or a related role.
• Strong knowledge of healthcare regulations such as HIPAA, FDA, CMS, and OSHA standards.
• Excellent organizational and communication skills.
• Proficiency in Microsoft Office Suite and regulatory management software.

Requirements

• Certification in Regulatory Affairs (RAC) or Certified Professional in Healthcare Quality (CPHQ) (preferred).
• Experience working within healthcare or social assistance organizations (preferred).
• Familiarity with electronic document management systems and compliance tracking tools (preferred).
• Advanced knowledge of federal and state healthcare laws and policies (preferred).
• Demonstrated ability to manage multiple projects and deadlines in a fast-paced environment (preferred).

Responsibilities

• Coordinate and prepare regulatory submissions and documentation for healthcare compliance.
• Monitor and interpret changes in healthcare regulations and communicate their impact to relevant departments.
• Maintain accurate records of regulatory activities, correspondence, and approvals.
• Collaborate with internal teams such as legal, clinical, and quality assurance to ensure compliance with regulatory standards.
• Assist in the development and implementation of policies and procedures to meet regulatory requirements.
• Track deadlines and ensure timely submission of all regulatory filings and reports.
• Support audits and inspections by regulatory agencies by preparing necessary documentation and facilitating communication.
• Provide training and guidance to staff on regulatory compliance matters.

Skills

• Strong organizational skills to manage multiple regulatory submissions and ensure documentation accuracy.
• Effective communication skills for liaising between regulatory agencies and internal teams.
• Analytical skills to interpret complex regulations and assess their impact on organizational policies.
• Proficiency with software tools for tracking deadlines, document management, and reporting.
• Problem-solving skills to address compliance challenges proactively and support continuous improvement in regulatory processes.