Regulatory Specialist: Average Salary in Burlington, MA in 2024

The Senior Business Controls Specialist (Regulatory Management Team) will complete reviews on commercial facilities and review applicability and complete subsequent tasks needed to satisfy the FR Y 14Q Schedule H. Analyze loan structure and apply both regulatory and internal guidance to satisfy the...

Related duties include participation on design and risk management teams, initiation of regulatory plans for both new products and significant product modifications, documentation of regulatory impact from device modifications, assistance in creating and maintaining Technical Files, labeling/adverti...

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 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 ...

Our client is seeking a Regulatory Documentation Specialist who will be responsible for overseeing, organizing, and preparing regulatory documentation essential for product approvals, compliance, and submissions to regulatory authorities. Regulatory Documentation Specialist. The Regulatory Documenta...

Experience building regulatory strategies to support successful regulatory affairs team. Develop, implement, and lead the regulatory regional strategy, in alignment with company goals, for new and sustaining ZOLL Resuscitation products and features. Develop and successfully implement regional regula...

The Senior Business Controls Specialist (Regulatory Management Team) will complete reviews on commercial facilities and review applicability and complete subsequent tasks needed to satisfy the FR Y – 14Q Schedule H. Analyze loan structure and apply both regulatory and internal guidance to satisfy th...

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 ...

Related duties include participation on design and risk management teams, initiation of regulatory plans for both new products and significant product modifications, documentation of regulatory impact from device modifications, assistance in creating and maintaining Technical Files, labeling/adverti...

Responsible for influencing department regulatory processes and procedures, developing strategies for worldwide regulatory approval, preparing US and EU submissions, and ensuring timely and high-quality execution of all regulatory deliverables. Senior Regulatory Affairs Specialist. Serve as RA Repre...

Regulatory Affairs Specialist - Labeling - Junior. Include specific internal and external relationships, product focus, regulatory requirements, physical demands, etc. Through coordination/collaboration with direct supervisor and with routine direction and guidance, review and remediate regulatory d...

Regulatory Specialist supports regulatory compliance for clinical research conducted by investigators in the department of emergency medicine at Beth Israel Deaconess Medical Center (BIDMC). Preparation and implementation of regulatory office SOPs and develops training materials and provides trainin...

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 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...

Actively participate in problem solving discussions and recommend solutions • Keep abreast of FDA guidance documents and regulations and monitor impact of changing regulations on submission strategies • Assist in the maintenance and improvement of regulatory SOPs • Interact and negoti...

Senior Quality Systems Specialist (Regulatory). Supplier Quality Regulatory Affairs. As a Quality System Specialist, you will act as the primary focal to interface with Boeing Suppliers, Business Partners and the Federal Aviation Administration on various complex Quality Management System related to...

Prepare IDE, 510(k), PMA, CE Mark, and other related regulatory filings. Develop and implement regulatory strategy for new technologies and product modifications. Interface with FDA and other regulatory agencies. Establish and implement policies and procedures related to Regulatory. ...

The principal specialist has primary responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions worldwide. Principal Regulatory Affairs Specialist – Surgical. The Principal Regulatory Affairs Spe...

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...

ICP Group is looking to identify a Product Safety & Regulatory Affairs Specialist. The PSRA Specialist ensures that all product-related activities (from development to post-commercialization) are conducted in accordance with the current domestic and global regulatory statutes that govern the res...

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...

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...

Our client is seeking a Regulatory Documentation Specialist who will be responsible for overseeing, organizing, and preparing regulatory documentation essential for product approvals, compliance, and submissions to regulatory authorities. Regulatory Documentation Specialist. The Regulatory Documenta...

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

Lead regulatory strategies for new and sustaining products that result in device approval. Provide regulatory perspective of internal and external documentation to support the development and commercialization of assigned product(s). Work with regional and product teams to ensure that regulatory req...