The Regulatory Operations Senior Publishing Specialist is responsible for the planning, creation, and submission of regulatory submissions. The Senior Publishing Specialist provides regulatory operations expertise to cross-functional submission project teams, promoting and bringing excellence in pla...
Regulatory Affairs Specialist to join our growing team. As a regulatory affairs specialist at BrioHealth Solutions Inc. Provide regulatory support for clinical and post-market activities including adverse event reporting, labeling updates and regulatory inquiries. Work with cross-functional teams to...
Providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified medical devices. Assist in the development of the regulatory strategies for new products and design changes - ensuring regulatory requirements for target markets are met. Preparin...
Regulatory Publishing Specialist. We are seeking a skilled Regulatory Affairs Publishing Contractor with extensive experience in regulatory submissions and a strong background in using Veeva for publishing activities. Collaborate closely with cross-functional teams including Regulatory Affairs, Qual...
Senior Regulatory Affairs Specialist. Responsible for managing product based regulatory activities of a medical device company that designs, manufactures, sells, and services medical imaging equipment. Manage preparation of regulatory documentation to facilitate the commercialization of new products...
Accreditation and Regulatory Specialist (Nurse) page is loaded Accreditation and Regulatory Specialist (Nurse) Apply locations Boston time type Full time posted on Posted Yesterday job requisition id 31071. Under the direction of the Senior Director, Accreditation & Regulatory and working collab...
The Principal Regulatory Affairs Specialist will play a critical role in preparing comprehensive regulatory strategies for complex new devices and post market changes within Philips’ Ultrasound business. Develop regulatory strategies and communicate risks within regulatory strategies vs project plan...
Compliance and Regulatory Security Specialist. The Global Compliance and Regulatory Security Specialist will be responsible for mapping our existing control framework (NIST CSF 2. The ideal candidate will have extensive experience in the global compliance and regulatory landscape, a strong understan...
The IACUC Regulatory Compliance Specialist has the overall responsibility for ensuring regulatory compliance within the areas of the animal care and use program that fall under the responsibility of the IACUC office. Completes and submits all required Federal and State reports and acts as a liaison ...
Regulatory Affairs Specialist (Medical Device). Work with cross-functional teams consisting of R&D, Quality and Regulatory to gain concurrence on gaps and needed actions to address. At least 5 years relevant experience within the regulatory affairs discipline. Knowledge of EU medical device regu...
Regulatory Contracts Coordinator/Specialist 2044987. This position is responsible for overseeing the regulatory contract process, from negotiating agreements and vendor setup to ensuring compliance and handling all related documentation. ...
Day (United States of America)The Regulatory Specialist supports regulatory compliance for oncology clinical research in the Cancer Clinical Trials Office (CCTO) at Beth Israel Deaconess Medical Center (BIDMC). Oversees reporting of AEs, SAEs, IND safety data, violations, deviations and submission o...
The successful candidate will support regulatory activities at Yield10 Bioscience including drafting, securing, and submission of USDA-APHIS BRS permits and notifications for movement and release of regulated crop material, overseeing regulatory matters of field trials, and supporting other regulato...
The Principal Regulatory Affairs Specialist will play a critical role in preparing comprehensive regulatory strategies for complex new devices and post market changes within Philips’ Ultrasound business. Develop regulatory strategies and communicate risks within regulatory strategies vs project plan...
Regulatory Validation and Relations Audit Specialist/Audit Services. The Regulatory Validation and Relations Audit Specialist is responsible for defining and ensuring the successful execution and delivery of validation approaches through engagement with all levels of management from across Audit Ser...
The role supports the EMEA/APAC/NA senior leaders to identify and oversee areas of regulatory change and remediation, working alongside other Regulatory Risk Management Specialists to ensure alignment on implementation and regulatory sustainability in BAU. The Regulatory Risk Management team is resp...
Interface with suppliers along with industry partners to ensure products and components meet regulatory compliance. Produce and maintain required compliance certificates, test reports to show conformance to regulatory requirements. Support regulatory compliance process improvement activities. ...
Under the direction of the Senior Director, Accreditation & Regulatory and working collaboratively, the Accreditation and Regulatory Specialist (Nurse) leads efforts to ensure continual organizational compliance and ongoing readiness with clinical quality and patient safety standards and regulations...
The Senior Specialist, Regulatory Affairs performs activities to support the regulatory submissions process through development of regulatory strategy and submission of materials to health authorities such as FDA for approval of novel platforms. Support and eventually manage interactions with regula...
The IACUC Regulatory Compliance Specialist has the overall responsibility for ensuring regulatory compliance within the areas of the animal care and use program that fall under the responsibility of the IACUC office. Job Description - IACUC Regulatory Compliance Specialist (3271795). Completes and s...
Regulatory Contracts Coordinator/Specialist 2044987. This position is responsible for overseeing the regulatory contract process, from negotiating agreements and vendor setup to ensuring compliance and handling all related documentation. ...
The role supports the EMEA/APAC/NA senior leaders to identify and oversee areas of regulatory change and remediation, working alongside other Regulatory Risk Management Specialists to ensure alignment on implementation and regulatory sustainability in BAU. The Regulatory Risk Management team is resp...
GLFHC is currently seeking a Pharmacy Operations, Credentialing and Regulatory Specialist. The Pharmacy Operations, Credentialing and Regulatory Specialist will be responsible for inventory reporting, co-pays, compliance audits, management of the contract process and support for inventory management...
The Regulatory Specialist implements and maintains assigned insurance data requirements for automated and manual programs to meet Enterprise and client management reporting requirements, insurance agencies, and insurance departments. You will lead regulatory reporting projects. You will complete reg...
Communicate directly with senior management, economic operators, and regulatory agencies on all regulatory issues. Regulatory Affairs in the medical device industry * Experience interacting with FDA regarding regulatory matters * Expertise in working within Medical Device Reg...