Jan 07, 2025
Clinical Regulatory Compliance Manager
- Apria Healthcare LLC
- Indianapolis, IN, United States
Full time
Legal
Job Description
At Owens & Minor, we are a critical part of the healthcare process. As a Fortune 500 company with 350+ facilities across the US and 22,000 teammates in over 90 countries, we provide integrated technologies, products and services across the full continuum of care. Customers—and their patients—are at the heart of what we do.
Our mission is to empower our customers to advance healthcare, and our success starts with our teammates.
Owens & Minor teammate benefits include:
Medical, dental, and vision insurance, available on first working day
401(k), eligibility after one year of service
Employee stock purchase plan
Tuition reimbursement
This role reports to the VP of Clinical Regulatory Compliance and provides day to day oversight of clinical regulatory compliance including but not limited to FDA regulations, accreditation standards, state licensure and regulatory requirements that affect facility operations. Ensure policies and procedures are incompliance with applicable federal, state and accrediting organizations. Serve as an internal resource for the organization’s business partners regarding clinical regulatory requirements.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Oversee the day-to-day activities of the organization's external Agency Inspection activity with federal and state regulatory requirements and accreditation standards as they apply to HME/RT, Medical Gas operations and other applicable company operations. Ensures regulatory requirements and accreditation standards are integrated into the policies and procedures of the company.
Assists in the interpretation and understanding of federal and state regulatory compliance in the field as they apply to the company's standard operating procedures.
Facilitates regulatory compliance problem identification and resolution.
Prepares and distributes compliance training materials.
Reviews incoming accreditation and regulatory compliance reports.
Coordinates correspondence and interactions with outside agencies.
Works with branches in the preparation and execution of the compliance action plans.
Assists in maintaining corporate compliance database and provide ongoing compliance data and reports.
Provides guidance upon request regarding application of new licenses and ongoing renewal of federal and state facility licensure and registration.
May be responsible for hiring, coaching, performance appraisal and disciplining of subordinate staff. Ensures project deadlines and performance standards are established and met
Advises internal management and business partners on applicable clinical regulatory requirements as they impact operations.
Assist in the review of communications regarding new products and internal form/policy development/revision prior to issuance
Conducts audits as assigned
Keep informed regarding state and federal regulatory changes, and industry changes that impact clinical regulatory compliance
Other duties as assigned
SUPERVISORY RESPONSIBILITIES
This position may be responsible for the performance management, hiring, and discipline of Teammates within the department.
MINIMUM REQUIRED QUALIFICATIONS
Education and/or Experience
RCP Degree is required
At least eight years related experience is required.
Clinical Regulatory Research Experience
Certificates, Licenses, Registrations or Professional Designations
Hold a current RCP license in state(s) of practice.
Hold registration or certification by the National Board for Respiratory Care (NBRC).
SKILLS, KNOWLEDGE AND ABILITIES
Leadership
Business Acumen
Strategic Thinking
Problem Solving/Analysis
Financial Management (Budgeting)
Project Management
Communication Proficiency
Personal Effectiveness/Credibility
Computer Skills
Computer savvy with: MS Excel, MS Office and MS Project required.
Language Skills
English (reading, writing, verbal)
Mathematical Skills
College level mathematical proficiency, with a strong ability to understand, interpret and develop spreadsheet data.
If you feel this opportunity could be the next step in your career, we encourage you to apply. This position will accept applications on an ongoing basis.
Owens & Minor is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, sex, sexual orientation, genetic information, religion, disability, age, status as a veteran, or any other status prohibited by applicable national, federal, state or local law.
Our mission is to empower our customers to advance healthcare, and our success starts with our teammates.
Owens & Minor teammate benefits include:
Medical, dental, and vision insurance, available on first working day
401(k), eligibility after one year of service
Employee stock purchase plan
Tuition reimbursement
This role reports to the VP of Clinical Regulatory Compliance and provides day to day oversight of clinical regulatory compliance including but not limited to FDA regulations, accreditation standards, state licensure and regulatory requirements that affect facility operations. Ensure policies and procedures are incompliance with applicable federal, state and accrediting organizations. Serve as an internal resource for the organization’s business partners regarding clinical regulatory requirements.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Oversee the day-to-day activities of the organization's external Agency Inspection activity with federal and state regulatory requirements and accreditation standards as they apply to HME/RT, Medical Gas operations and other applicable company operations. Ensures regulatory requirements and accreditation standards are integrated into the policies and procedures of the company.
Assists in the interpretation and understanding of federal and state regulatory compliance in the field as they apply to the company's standard operating procedures.
Facilitates regulatory compliance problem identification and resolution.
Prepares and distributes compliance training materials.
Reviews incoming accreditation and regulatory compliance reports.
Coordinates correspondence and interactions with outside agencies.
Works with branches in the preparation and execution of the compliance action plans.
Assists in maintaining corporate compliance database and provide ongoing compliance data and reports.
Provides guidance upon request regarding application of new licenses and ongoing renewal of federal and state facility licensure and registration.
May be responsible for hiring, coaching, performance appraisal and disciplining of subordinate staff. Ensures project deadlines and performance standards are established and met
Advises internal management and business partners on applicable clinical regulatory requirements as they impact operations.
Assist in the review of communications regarding new products and internal form/policy development/revision prior to issuance
Conducts audits as assigned
Keep informed regarding state and federal regulatory changes, and industry changes that impact clinical regulatory compliance
Other duties as assigned
SUPERVISORY RESPONSIBILITIES
This position may be responsible for the performance management, hiring, and discipline of Teammates within the department.
MINIMUM REQUIRED QUALIFICATIONS
Education and/or Experience
RCP Degree is required
At least eight years related experience is required.
Clinical Regulatory Research Experience
Certificates, Licenses, Registrations or Professional Designations
Hold a current RCP license in state(s) of practice.
Hold registration or certification by the National Board for Respiratory Care (NBRC).
SKILLS, KNOWLEDGE AND ABILITIES
Leadership
Business Acumen
Strategic Thinking
Problem Solving/Analysis
Financial Management (Budgeting)
Project Management
Communication Proficiency
Personal Effectiveness/Credibility
Computer Skills
Computer savvy with: MS Excel, MS Office and MS Project required.
Language Skills
English (reading, writing, verbal)
Mathematical Skills
College level mathematical proficiency, with a strong ability to understand, interpret and develop spreadsheet data.
If you feel this opportunity could be the next step in your career, we encourage you to apply. This position will accept applications on an ongoing basis.
Owens & Minor is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, sex, sexual orientation, genetic information, religion, disability, age, status as a veteran, or any other status prohibited by applicable national, federal, state or local law.
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