Regulatory Compliance Manager

Job Summary: As a Regulatory Compliance Manager, you will be working in a fast-paced, rapidly growing environment where you will be relied on for your expertise, professionalism, and collaboration. This is a full-time, in-person role, in our office located in Stamford, CT. Usual hours will be 9:00am-5:00pm in the office. The Regulatory Compliance Manager is responsible for ensuring the NEFI center/other business units such as AlphaCord and CryoChoice adheres to all relevant laws, regulations, and professional standards, such as those from the FDA, HIPAA, and different state licensing bodies. Key duties include developing policies, conducting audits, training staff, managing compliance-related reporting, serving as a liaison with regulatory bodies, and collaborating with clinical, laboratory and administrative teams to maintain a culture of ongoing quality improvement and patient safety.

Core duties and responsibilities

• Compliance program management: Design, develop, and manage a comprehensive compliance program, including drafting and revising policies, procedures, and a code of conduct for the entire center.

• Regulatory interpretation and monitoring: Stay current with all regulations impacting fertility services, such as those from the Food and Drug Administration (FDA) regarding Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P), as well as HIPAA, OSHA, and other state and federal healthcare laws.

• Inspections and audits: Prepare for and act as the primary point of contact for regulatory inspections and internal audits. This includes coordinating documents, staff, and corrective action plans.

• Internal audits and risk assessment: Conduct regular internal audits and risk assessments to identify potential areas of non-compliance. Develop and implement corrective action plans to resolve any issues found.

• Documentation and reporting: Ensure all required documentation is accurate, complete, and maintained according to regulatory standards. This includes patient records, donor records, and reporting to regulatory agencies.

• Training and education: Provide ongoing training and guidance to employees on regulatory requirements and internal compliance policies. Foster a culture of compliance throughout the organization.

• Strategic guidance: Advise senior management on compliance risks and the potential impact of new or evolving regulations on the center's operations and strategies.

• Issue investigation: Investigate and resolve alleged violations of rules and policies, ensuring that concerns are appropriately evaluated and addressed.

• SART protocol management: Oversee and implement clinic-wide procedures and workflows for data collection, validation, and submission to the SART Registry. This ensures a consistent and accurate reporting process while working with clinical and lab staff to ensure all necessary data points are meticulously captured.

• Responsible for comprehensive training for new medical assistants on critical regulatory topics, including HIPAA, FDA HCT/P protocols, patient consent, and SART data accuracy, ensuring that MAs are fully compliant with all relevant policies and procedures from their first day and that their training records are properly maintained.

• New Updates and Workflow Enhancements: Stay informed about updates and advancements in the eIVF program (Electronic Health Record system) and other relevant technologies. Collaborate with IT and software vendors to implement new features, enhancements, and workflow optimizations to improve efficiency and usability.

• Training on eIVF Program: Develop and conduct training sessions for new and existing staff members on the eIVF program, covering basic functionalities, best practices, and workflow protocols. Provide ongoing support and guidance to ensure staff members are proficient in using the eIVF program to streamline patient care and administrative tasks.

• Implementation of Program Changes: Lead efforts to implement changes and updates within the eIVF program to address workflow inefficiencies, enhance usability, and improve patient outcomes. Collaborate with stakeholders to gather feedback, prioritize enhancements, and oversee the rollout of changes while minimizing disruptions to daily operations.

• Performs other duties as assigned: Please note this job description is not designed to cover or contain a comprehensive listing of essential functions and responsibilities, and the employee may perform other related duties to meet the ongoing needs of NEFI/AlphaCord/CryoChoice. Job responsibilities and duties may change at any time with or without notice.

Experience: Minimum of 3 years of fertility industry experience.

Other Requirements:

• Strong communication skills & a team player

• Flexibility and Reliability

• Detail oriented

• Exemplifies strong customer service skills and professionalism

• Maintain a high degree of confidentiality

Performance Requirements: Knowledge:

1. Knowledge of medical terminology

2. Knowledge of common safety hazards and precautions to establish/maintain a safe work environment.

3. Knowledge of health promotion, health risk identification, and patient education principles and techniques.

4. Knowledge of community, professional, and educational resources.

5. Knowledge of practice management systems including electronic health record systems (EHRs).

Skills:

1. Skill in oral and written communication; providing presentations, consultations, and documentation

2. Skill in time management, problem solving, multitasking, and other organizational matters.

Abilities:

1. Ability to interpret, adapt, and apply guidelines and procedures.

2. Ability to establish/maintain effective working relationships with patients, staff, and the public.

3. Ability to competently use Microsoft Office and appropriate practice management software.

4. Ability to interact with patients in a caring and thoughtful manner.

5. Ability to prioritize tasks and work with interruptions.

• Strong project management skills with the ability to coordinate multiple initiatives simultaneously.

• Familiarity with eIVF program or similar electronic health record systems preferred.

• Ability to work collaboratively with cross-functional teams and communicate effectively with stakeholders at all levels of the organization.

• Thorough understanding of healthcare laws, regulations, and industry standards, including HIPAA, Stark Law, Anti-Kickback Statute, and Medicare/Medicaid regulations.

• Strong analytical, problem-solving, and decision-making skills.

• Excellent communication, presentation, and interpersonal skills.

• Ability to work collaboratively with cross-functional teams and influence stakeholders at all levels of the organization.

Equipment Operated: Using computer/health information management system. Work Environment: Medical office.

Job Type: Full-time

Pay: $71,825.95 - $86,500.06 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Vision insurance

Work Location: In person

Salary : $71,826 - $86,500