Regulatory Affairs Specialist, Senior

Nemours is seeking a Regulatory Affairs Specialist, Senior to join our Nemours Children's Health team in Wilmington, DE.

This is a hybrid position.

The Senior Regulatory Affairs Specialist is responsible for the successful implementation of regulatory goals and objectives.

Accountable for creating a culture of continuous regulatory readiness through proactive risk assessment and mitigation efforts.

Essential Functions

• Oversees and facilitates regulatory educational offerings including internal and external presentations

• Oversee JC Accreditation website and communicate to appropriate audiences.

Maintains documents necessary for the system.

• Maintains up to date knowledge of JC/CMS/State regulations for all applicable programs, as evidenced by direct observation by leadership.

• Outlines/ leads regulatory project initiatives with deadlines to keep groups on task.

• Prepares reports on activities as needed for informing clinical, operations, and financial stakeholders, on time and errorfree.

• Leads attendance of needed departmental personnel in annual hospital training programs as required by The Joint Commission, law, or regulatory authorities.

• Provides/leads at least three (3) educational sessions in one calendar year within the System.

• Mentors' facilitation skills and partners with clinical leaders on projects to lead team.

• Conducts consultative mock surveys independently throughout the IDS.

Evidenced by direct observation of leadership and customer feedback.

• Oversees departmental projects and tasks to ensure progression of departmental work portfolio.

• Acts as a Facilitator or Team Leader on projects as assigned.

• Independently conducts special projects as assigned at the direction of leadership.

• Independently provides regulatory consulting and analysis services to staff and physicians.

• Serves as Nemours liaison to JCR for coordination, scheduling, contracting, and billing of mock survey visits.

• Communicates with Joint Commission SIG group for questions regarding interpretation of accreditation issues.

Inform appropriate parties of SIG ruling.

• Oversees and coordinates education and training to the AMP end users.

• Represents Accreditation at DV committee meetings and programs, as assigned.

(may sit on committee but not sole representation)

• Ability to lead, facilitate, and participates in actual unannounced JC/CMS/State surveys.

Role includes pre-planning, education, active participation in survey, and required follow-up.

• Leads annual Intracycle monitoring (ICM).

Report findings and develop action plans.

Monitor metrics monthly as required.

• Leads in the internal mock survey program, which includes planning, development of tools, training, conducting mock surveys, reporting findings and follow-up as needed

Requirements

Bachelor's Degree

Minimum of five years of progressive hospital/healthcare experience required

RN or other clinical certification pre...