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 regulat...
Handle projects and other regulatory filings related to MFS's investment advisory and retail distribution business. Bachelor's degree or equivalent years' work experience with 5-6+ years of legal or regulatory experience. ...
The Principal Regulatory Specialist is responsible for carrying out Pre-Market and Post-Market regulatory activities in compliance with Digital Factory's Quality Management System for domestic and various international markets for SaMD products. Conceive of and Implement the Regulatory Strategy in ...
Title: Senior Regulatory Affairs Specialist-Animal Tissue. Candidate will be responsible for regulatory activities related to Animal Tissue. Will report to the VP of Regulatory Affairs. Respond to regulatory authorities of any questions related to animal tissue. ...
Senior Regulatory Affairs Specialist-Animal Tissue. ...
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...
As a Principal Regulatory Affairs Specialist at Verily, you will work directly with other Regulatory Affairs team members, partners and a team of experts from diverse fields (e. Biology, Chemistry, Physics, Electrical Engineering, Computer Science) to develop, manage and execute regulatory strategie...
Title: Senior Regulatory Affairs Specialist-Animal Tissue. Candidate will be responsible for regulatory activities related to Animal Tissue. Will report to the VP of Regulatory Affairs. Respond to regulatory authorities of any questions related to animal tissue. ...
PathAI is seeking an experienced Principal Regulatory Affairs Specialist to play a key role in supporting regulatory strategies and ensuring the success of our diagnostic products in the global market. Oversee regulatory operations, including the management of regulatory documentation, tracking of s...
Review Change Orders and assess regulatory impact of product changes on US and/or EU regulatory strategy and submissions per standard procedures. Develop US and EU regulatory strategies for product submissions, identifying needs for bench, animal and clinical testing. Assist in keeping company infor...
The Regulatory Affairs Specialist (RAS) positions provides advanced expertise and regulatory support to + investigators and research staff members at DFCI, focusing on standards and techniques for performing job functions typical in the development and/or conduct of FDA regulated research from an op...
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...
We are seeking a Regulatory Affairs Specialist to assist in the development of regulatory strategy, manage the execution of regulatory plans, and perform other activities that lead to and maintain device registrations. Develop and implement regulatory strategies for new and existing products. Suppor...
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...
As the Clinical Regulatory Affairs Specialist, you will play a critical role in managing essential documentation and regulatory submissions that are key to our clinical trials' success. You will ensure the success of clinical trials by overseeing the submission of regulatory packages, managing IRB a...
Regulatory Affairs Specialist (Level II or Senior Level). BS Degree in Sciences, or equivalent MS in Regulatory Affairs is preferred. ...
Our client is currently seeking a Senior Regulatory Compliance Specialist. Monitor international standards and guide regulatory testing requirements. Assist with risk analysis and regulatory submissions. ...
The Regulatory Affairs Specialist performs activities to support the regulatory submissions process through development of regulatory strategy and submission of materials to the FDA for approval of novel platforms. Support and eventually manage interactions with regulatory agencies including respons...
The Principal Regulatory Affairs Specialist will play a critical role in preparing comprehensive regulatory strategies and post market changes for complex, new/existing Ultrasound systems/devices. Develop regulatory strategies and communicate risks within regulatory strategies vs project plan, and o...
Title: Senior Regulatory Affairs Specialist-Animal Tissue Location: Burlington MA Schedule: Monday through Friday on site Terms: Direct Hire Education: Bachelor's degree from four-year college or university, preferably in biology, microbiology, virology, animal science, or veterinary. Requireme...
Support the IVDR project by revising the assigned technical files.Each technical file must be generated using the latest technical file template and it must clearly present the product.Must attend multiple weekly meetings which are intended to help address issues or questions regarding the technical...
Senior Regulatory Affairs Specialist-Animal Tissue. Candidate will be responsible for regulatory activities related to Animal Tissue . Will report to the VP of Regulatory Affairs . Respond to regulatory authorities of any questions related to animal tissue. ...
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...