Job Application - Madison Health

Job Posting OPEN

Executive Director-Regulatory Affairs-(Exempt)

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Regulatory Compliance Oversight:

1.      Ensure compliance with healthcare regulations, such as FDA, HIPAA, CMS, and other applicable standards.

2.      Manage submissions to regulatory agencies for product approvals, certifications, and renewals.

 

Policy Development:

3.      Develop and implement compliance policies and procedures.

4.      Stay updated on changes in healthcare regulations and ensure organizational alignment.

 

Cross-Functional Collaboration:

5.      Work with departments such as clinical, legal, research, and quality assurance to address regulatory requirements.

6.      Provide guidance on regulatory strategies and risk management.

 

Team Leadership:

7.      Lead and mentor a team of compliance or regulatory specialists.

8.      Oversee training programs to educate staff on regulatory requirements.

 

Audit and Reporting:

9.      Conduct internal audits to assess regulatory risks.

10.  Serve as the point of contact during external audits or inspections by regulatory bodies.

 

Regulatory Compliance

11.  Responsible for maintaining interdepartmental quality controls and providing support with departmental participation in performance improvement. Uphold the responsibility and authority for directing the management operations and clinical practice for Quality Improvement. This position participates in functional decision-making processes necessary to the successful attainment of the hospital’s mission and goals.

12.  Responsible for Risk Management and Legal coordination to identify, assess and mitigation strategies to control potential events or condition that could lead errors or injury.

13.      Oversee Medical Staff Office and support the efforts of credentialing, privileging, compliance, training of medical staff.

14.      Responsible for case management activities to coordinate the comprehensive care of patients to be improve patient outcomes as they are navigated through the healthcare experience. 

Schedule- Exempt


Required Skills: 

1. Thorough knowledge and understanding of patient care principles and practices; good managerial skills; effective oral and written communication skills; judgment, tact, and diplomacy; strong interpersonal abilities; critical thinking skills; and the ability to chair and participate in unit leadership teams and other committees.

 

      Minimum Work Experience:  

1. A minimum of five (5) years of Risk Management, Quality/Performance Improvement experience within a healthcare setting

 

      Minimum Education: 

1.      Master’s degree in healthcare, life sciences, regulatory affairs, or a related field.

2.      5–10 years of experience in regulatory compliance, ideally in healthcare or pharmaceuticals.

3.       Certifications such as CPHRM (Certified Professional in Healthcare Risk Management), CPHQ (Certified Professional in Healthcare Quality), HCQM (Healthcare Quality Management Certification) or  RAC (Regulatory Affairs Certification) are preferred.