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Director, Global Regulatory Strategy

Proclinical Staffing  –  Boston, MA, 02298
... Experience with running submissions and FDA meetings. Ability to manage complex issues and coordinate multiple projects simultaneously. Strong interpersonal and written/verbal communication skills. Proven track record practicing sound judgment as it ... - Jun 15

Clinical Trial Manager

EPM Scientific  –  Boston, MA, 02298
... Ensure compliance with Good Clinical Practice (GCP), FDA regulations, and international guidelines. Coordinate with internal and external stakeholders, including CROs, vendors, and clinical sites. Prepare and review study-related documents, ... - May 25

Director, Global Regulatory Strategy

Aquinas Consulting  –  Boston, MA, 02298
... Representing the company as point contact FDA and leading delegation for regulatory authority meetings. Leading US submissions to regulatory authorities in support of proposed and ongoing development programs, e.g., new clinical trial protocols, new ... - Jun 18

Head of Quality Assurance

G&H Staffing Companies (Temp-Secure Staffing and  –  Billerica, MA, 01821
... Ensure compliance of establish Quality Management System (QMS) and in compliance with corporate requirements and all applicable FDA Part 4, Part 210/211, Part 820, ISO 13485 and Canadian Medical Devices Regulations (CMDR SOR/98-282), EU Medical ... - Jun 18

Freezer Order Picker

North Coast Seafoods  –  Boston, MA
... manipulation, pushing and pulling Work requires the following motions: bending, twisting, squatting and reaching Exposure to FDA approved cleaning chemicals Exposure to temperatures: <32 degrees Fahrenheit Ability to work in wet and dry conditions ... - Jun 07

Human Research Compliance and Auditing Specialist

Mass General Brigham  –  Somerville, MA, 02145
... IRB-approved clinical research protocols across our institutions to ensure compliance with FDA, OHRP and other state and government regulations, Good Clinical Practice (GCP) guidelines, as well as with our organization's clinical research policies. ... - May 25

Procurement Specialist

Mentor Technical Group  –  Boston, MA
Job Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and ... - May 23

Quality Control Technician

North Coast Seafoods  –  Boston, MA
... manipulation, pushing and pulling Work requires the following motions: bending, twisting, squatting and reaching Exposure to FDA approved cleaning chemicals Exposure to temperatures: <32 degrees Fahrenheit Ability to work in wet and dry conditions ... - Jun 17

Associate Director, Regulatory Affairs CMC

CRISPR Therapeutics  –  South Boston, MA, 02127
... Current knowledge of FDA, EMA and ICH regulations/guidance and requirements, with a demonstrated ability to articulate and apply these principles to Regulatory CMC strategies for novel products. Working knowledge of eCTD requirements for submission ... - Jun 13

Lead Software Engineer - Qt

Motion Recruitment  –  Boston, MA, 02298
... Ensure compliance with regulatory standards, such as FDA regulations and ISO standards, throughout the software development lifecycle. Participate in design reviews, risk assessments, and technical discussions to identify and address potential ... - Jun 09
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