What are the responsibilities and job description for the Regulatory Affairs Specialist position at NemoursCareerSite?
Nemours is seeking a Regulatory Affairs Specialist to join our team in Wilmington, DE.
Under the direction of the Manager of Regulatory & Accreditation Affairs, the 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:
- Conduct regular assessments through audits (formal and informal) mock tracers and mock surveys. Respond to actual or potential noncompliance by ensuring appropriate corrective action is taken to successfully eliminate the risk of deficiency and continue to monitor for sustained compliance
- Manage aspects of investigations, inspections and surveys conducted by regulatory and accrediting agencies; prepare for and facilitate regulatory visits and construction occupancies, oversight of the regulatory surveyors; respond to the deficiencies by ensuring appropriate corrective measures have been taken which eliminate the deficiency
- Create a culture of regulatory readiness through continual proactive measures. Educate all levels of staff on regulatory requirements, regulations, and standards in development
- Coordinates verbal and written communication with The Joint Commission (TJC) and other regulatory bodies.
- Works closely with medical staff, nursing/hospital staff, and department directors and managers to ensure ongoing regulatory and accreditation readiness and compliance.
- Coordinates and participates in the execution of educational activities and the development of educational materials for continuous readiness preparation at all levels of staff, including nursing, other patient care providers, other non-clinical hospital staff as appropriate, Medical Staff and Administration.
- Supports the Manager in managing regulatory and accreditation compliance initiatives. Identifies major phases implementation steps key stakeholders’ timelines resource needs and potential obstacles or issues for escalation.
- Ensures TJC and other regulatory compliance by advising departments services and committees of relevant specific accreditation and regulatory interpretations and any changes to previous regulations. Interprets standards for evidenced-based care as required. Provides instruction on TJC regulations and information on models for clinical improvement efforts. Contacts those responsible for reporting data to determine status and collaborates as needed to achieve compliance with program specifications.
- Coordinates and facilitates functional tracer teams to determine compliance and recommend improvement in operational processes.
- Assist with facilitation functional tracer teams to determine compliance and recommend improvement in operational processes.
- Oversees the development and implementation of an action plan for each of the functional chapters to ensure consistency and improvement of identified non-compliance issues
- Other related duties
- Regulatory Committee management, preparation, and communications
- Ownership of all regulatory administrative duties including organizational updates, communications, data awareness, etc.
- Assist with creating organizational action plans and monitoring compliance
- Ability to assume lead in regulatory initiatives
- Independent facilitation of regulatory related projects
Job Requirements:
- HS degree or equivalent required; Bachelor's degree preferred
- RN or other clinical certification preferred
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