events reporting, filing and archiving of study records, and resolution of data queries. Prepare and/or complete regulatory... with collaborators and regulatory authorities. Interact with study participants as directed/required by the protocol and/or study team...
and clinical efficiencies in EPIC In all activities complies with accreditation, legal and regulatory requirements. Maintains...
compounding processes, assuring full compliance with applicable regulatory requirements, standards, and policies...
volume venue or health / regulatory department preferred Ability to legally travel within the United States and Canada...
in a timely fashion. Understand the regulatory compliance ordinances and inspection protocols specific to each assigned location...
clinical currency. 10. Act in compliance with Heritage Healthcare’s regulatory and professional standards and guidelines...
regulatory due diligence into daily activities and long-term strategies for clients Desired Qualifications: Proven...
. Maintaining a core understanding of the medical device regulatory process in collaboration with Regulatory Affairs and providing... findings related to design control and regulatory compliance. Ensuring robust ISO14971 risk management processes...
: · Manages the setup and closure of new and existing EA Rapid Shelter Track locations, ensuring all logistical and regulatory...
documentation. Compliance & Safety: Ensure adherence to all safety standards, facility-related protocols, and local regulatory...
and/or regulatory compliance programs are completed accurately and within the required time frame. Assist with bookkeeping activities...
and clinical efficiencies in EPIC In all activities complies with accreditation, legal and regulatory requirements. Maintains...
Quality System Innovation: Design and implement cutting-edge quality system processes that not only comply with regulatory.... Deep familiarity with regulatory standards including 21 CFR 820, ISO 13485:2016, and IEC 62304:2006. Proven track record...
compliance with regulatory and accreditation standards Other projects and duties as assigned. What You Will Bring...
and regulatory requirements. Ensures the integrity and quality of patient data to achieve minimal variation in coding practices... and procedures in accordance with department, hospital, and regulatory requirements. 5. Submits queries to providers as needed when...
to human subjects protections. Maintains regulatory binders, case report forms, source documents, and other study documents...
standards and in compliance with internal SOPs, local regulations, GCP and regulatory requirements. You will ensure clinical... and discuss with key external experts, experts in basic science, as well as commercial and regulatory functions. Our therapy area-aligned...
and implementation of sediment remediation strategies. You will collaborate with multidisciplinary teams, clients, and regulatory... agencies to achieve project objectives and regulatory compliance. We are open to having the candidate work from any location...
development and lead them towards regulatory submission. You will be responsible for: Lead and driving gene therapy programs... and external collaborators. Support regulatory submissions, publications and presentations at scientific conferences...
ability to drive high-level technical decisions, manage large-scale projects, and interact with clients and regulatory agencies at the... direction, technical quality, and regulatory compliance of multiple projects while mentoring junior and mid-level staff...