Regulatory Affairs Specialist: Average Salary in Newton, MA in 2024

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 ...

Senior Regulatory Affairs Specialist-Animal Tissue. ...

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. Minimum of 3 years regulatory affai...

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 (Medical Device). At least 5 years relevant experience within the regulatory affairs discipline. Work with cross-functional teams consisting of R&D, Quality and Regulatory to gain concurrence on gaps and needed actions to address. Knowledge of EU medical device regu...

Regulatory Affairs Specialist (Level II or Senior Level). BS Degree in Sciences, or equivalent MS in Regulatory Affairs is preferred. ...

Regulatory Affairs Specialist Animal Tissue will report to the VP of Regulatory Affairs and have the following primary responsibilities:. Candidate will be responsible for regulatory activities related to Animal Tissue. Respond to regulatory authorities of any questions related to animal tissue. ...

Compiles documentation for regulatory submission packages including license renewals, updates and market registration for review and submission to regulatory agencies. Author and review high-quality, compliant CMC regulatory documents (e. Core Dossiers, INDs, CTAs, MAAs, BLAs, Variations and other r...

This position is part of the Quality Assurance and Regulatory Affairs group located in Coralville, IA, USA and will be remote. Author and/or review regulatory documents for global market entry, Design History Files, and perform regulatory activities in support of CAPAs, recalls, and medical device r...

Review Change Orders and assess regulatory impact of product changes on US and/or EU regulatory strategy and submissions per standard procedures. Develop and maintain regulatory affairs department procedures and process improvements. Regulatory Affairs Certification. Master's degree in Regulatory Af...

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...

Senior Regulatory Affairs Specialist-Animal Tissue. Will report to the VP of Regulatory Affairs . Candidate will be responsible for regulatory activities related to Animal Tissue . Respond to regulatory authorities of any questions related to animal tissue. ...

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. Bachelor's degree in Life Sciences, Regulatory Affairs, or a related field. You will ensure the success of clinica...

Yield10 is searching for a Regulatory Affairs Specialist. 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 regulat...

Regulatory Affairs Specialist (Level II or Senior Level). BS Degree in Sciences, or equivalent MS in Regulatory Affairs is preferred. ...

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...

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 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...

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. Able to t...

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...