Regulatory Affairs Specialist

6 days ago


Wilmington, United States Nrharural Full time

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: Bachelor's degree required RN or other clinical certification preferred Five (5) years progressive hospital/healthcare experience preferred. Minimum one (1) year experience in assigned specialty area preferred. Knowledge of Joint Commission, Centers for Medicare/Medicaid Services (CMS) or State Health Department regulations preferred. Strong project management experience Excellent communication (both written and oral), strong interpersonal and leadership skills. Ability to prioritize and function effectively with teams.

#J-18808-Ljbffr



  • Wilmington, United States Masis Professional Group Full time

    Medical Affairs Specialist, US (Oncology, Endocrinology, Radiopharmaceuticals)Location: Hybrid - NYC or MACompany Overview:Join a small but groundbreaking radiopharmaceutical development organization that retains its start-up spirit and is deeply committed to advancing patient care and developing new radiodiagnostic and radioligand therapy. They are...


  • Wilmington, United States Nikang Therapeutics Inc Full time

    Job DescriptionJob DescriptionPosition Summary: Reporting to the Executive Director of Regulatory Affairs and Quality Assurance, this position will provide strategic and operational expertise to support submissions to the FDA and other Health Authorities. The Director, Regulatory Affairs will be an integral and highly visible contributor to the team. This...


  • Wilmington, United States Meet Full time

    Senior Director, Regulatory Affairs CMC Hybrid - Philadelphia, PA Meet has partnered with a very well-established pharma with hundreds of approved products. They are looking for a Senior Director of Regulatory CMC (biologics) to join their team. This position will be working across the company's mid-stage, new development pipeline and will be reporting into...


  • Wilmington, United States GE Vernova Full time

    Job Description Summary The New Plant/Product (NPP) Licensing Manager will establish the vision & strategy and drive execution for Regulatory Affairs to accelerate the licensing needed to deploy new technologies. Responsible for managing teams and providing leadership and strategic guidance for new plant and product licensing activities in GEH and GNF....


  • Wilmington, Delaware, United States IFF Family of Companies Full time

    Job DescriptionSr. Specialist, Reg Affairs NAM - RemoteIt's an exciting time to be part of IFF, we are looking for our next Senior Analyst of North America Global Regulatory Affairs (GRA) to become a part of our industry-leading North America team. Are you passionate about building deep relationships and developing a growing sales portfolio with an industry...


  • Wilmington, United States IFF Family of Companies Full time

    Job Description Sr. Specialist, Reg Affairs NAM - Remote   It’s an exciting time to be part of IFF, we are looking for our next Senior Analyst of North America Global Regulatory Affairs (GRA) to become a part of our industry-leading North America team. Are you passionate about building deep relationships and developing a growing sales portfolio with an...


  • Wilmington, United States LANXESS Full time

    **Who we are**: LANXESS is a leading specialty chemicals company with sales of EUR 7.6 billion in 2021 and more than 13,000 employees in 33 countries. The core business of LANXESS is the development, manufacturing and marketing of chemical intermediates, additives, specialty chemicals and plastics. LANXESS is listed in the leading sustainability indices Dow...


  • Wilmington, United States Masis Professional Group Full time

    Medical Affairs Manager, US (Oncology, Endocrinology, Radiopharmaceuticals)Location: Hybrid - NYC or MACompany Overview:Join a small but groundbreaking radiopharmaceutical development organization that retains its start-up spirit and is deeply committed to advancing patient care and developing new radiodiagnostic and radioligand therapy. They are currently...

  • Regulatory Specialist

    4 weeks ago


    Wilmington, United States State of Delaware Full time

    **Essential Functions**: Essential functions are fundamental, core functions common to all positions in the class series and are not intended to be an exhaustive list of all job duties for any one position in the class. Since class specifications are descriptive and not restrictive, incumbents can complete job duties of similar kind not specifically listed...

  • Regulatory Specialist

    4 weeks ago


    Wilmington, United States DelDOT Full time

    Summary Statement Delaware has a new mandate to give workers paid leave to bond with a new child or to tend to their own or a loved one’s illness or injury and this position will support that effort. The person who fills this position will help the Division of Paid Leave interpret and apply the relevant laws, regulations, and procedures implement and...

  • Regulatory Specialist

    3 weeks ago


    Wilmington, Delaware, United States State of Delaware Full time

    Essential Functions: Essential functions are fundamental, core functions common to all positions in the class series and are not intended to be an exhaustive list of all job duties for any one position in the class. Since class specifications are descriptive and not restrictive, incumbents can complete job duties of similar kind not specifically listed here....


  • Wilmington, United States Incyte Full time

    Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health...


  • Wilmington, North Carolina, United States Asklepios Biopharmaceutical Full time

    Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered. At AskBio,...


  • Wilmington, North Carolina, United States Novartis Full time

    About the RoleThis is a Remote Position1.To author, review and manage high quality clinical and safety documents: complex Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Risk Management Plans (RMP), submission documents (e.g., summaries of clinical efficacy and safety, summaries of clinical pharmacology and biopharmaceutics).2.Core...


  • Wilmington, Delaware, United States IFF Family of Companies Full time

    Requisition ID : 492289 Job DescriptionThe Pharma Solutions business will be taking on its next chapter of growth as a trusted partner for thepharmaceutical industry with the announcement to sell Pharma Solutions to Roquette. This move will position Pharma Solutions to expand its industry leadership through continued investment in innovation to meet the...


  • Wilmington, Delaware, United States Army National Guard Full time

    Job DescriptionIf you're interested in the law and the legal profession, become an Army National Guard Paralegal, you will assist judges, Army lawyers, and unit commanders with legal matters and judicial work. The Paralegal Specialist provides legal and administrative support in areas like family law, international law, contract law, defense legal services,...


  • Wilmington, United States Nemours Foundation Full time

    This is a remote position. Under the direction of the OSP Manager, Grant Administration and Pre-Award Management, the Office of Sponsored Projects Award Specialist I provides pre-award services to help Nemours research investigators develop and submit grant and other sponsored project proposals and administer the awards after they are received. The OSP...


  • Wilmington, United States Agilent Technologies, Inc. Full time

    Designs and develops product safety procedures and monitoring strategies to ensure compliance with national and international regulations and regulatory agency requirements. Develops, implements, and manages key performance metrics to measure product Manager, Specialist, Manufacturing, Management


  • Wilmington, Delaware, United States Nemours Foundation Full time

    This is a remote position.Under the direction of the OSP Manager, Grant Administration and Pre-Award Management, the Office of Sponsored Projects Award Specialist I provides pre-award services to help Nemours research investigators develop and submit grant and other sponsored project proposals and administer the awards after they are received. The OSP Award...


  • Wilmington, United States IFF Family of Companies Full time

    Requisition  ID : 492289  Job Description The Pharma Solutions business will be taking on its next chapter of growth as a trusted partner for the pharmaceutical industry with the announcement to sell Pharma Solutions to Roquette. This move will position Pharma Solutions to expand its industry leadership through continued investment in innovation to...