| Job alert | Jobs 41 - 50 of 835 |
Senior Manager, US Medical Review
Alexion Pharmaceuticals, Inc.
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Boston, MA, 02298
... * Understanding of drug development, US (FDA)and global (e.g. EMEA) regulations and reporting requirement for reporting pharmacovigilance events and product quality complaints * Strong written and verbal communication skills * Proficiency in ... - Jun 08
Quality Assurance Manager
G&H Staffing Companies (Temp-Secure Staffing and
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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
Senior Quality Assurance Engineer
T2 Biosystems
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Lexington, MA
... Bachelor’s Degree in engineering related discipline required Minimum of 3 years of relevant Quality Management experience in an FDA regulated environment required, ideally within medical device or in vitro diagnostics industry ASQ or Six Sigma ... - Jun 01
Sr. Director Toxicology/DMPK
Delix Therapeutics
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Bedford, MA, 01730
... Delix is advancing these compounds through preclinical and clinical development to bring patients FDA-approved medicines that will address significant unmet needs. Headquartered in Massachusetts, Delix is building a world-class biotechnology company ... - Jun 18
Associate Director, US Regulatory, Advertising & Promotion
Ipsen Biopharmaceuticals, Inc.
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Cambridge, MA, 02138
... The Director is responsible for leading interactions with the FDA Office of Product and Drug Promotion pertinent to assigned brand(s). The individual will be responsible for all submission types made to OPDP/FDA. The incumbent's responsibility ... - Jun 13
Quality Control Manager
North Coast Seafoods
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Boston, MA
... root cause analysis and corrective action Plan, prepare and participate in all audits including: organic, kosher, customer, FDA, internal and 3rd party Sustain and improve ratings on annual certifications Performs other related duties as assigned ... - Jun 03
Associate Director of Manufacturing
DSJ Global
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Boston, MA, 02298
... Regulatory Compliance: Ensure all manufacturing activities comply with FDA, EMA, and other relevant regulatory agencies. Prepare and review documentation required for regulatory submissions and audits. Stay updated on industry regulations and ... - Jun 18
Director, Regulatory CMC iPSC Derived Cellular Therapies
ERAPS B.V.
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Cambridge, MA, 02142
... Comprehensive knowledge of regulatory (FDA. EMA, Health Canada and ICH) guidelines Experience with development and/or improvement of department processes/procedures Proven ability to impact and influence the decisions of a team and decision-making ... - Jun 14
Principle Device Quality Engineer, Combination Product Lead & Risk
Biogen
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Cambridge, MA
... Ensuring that all design activities adhere to FDA Quality System Regulations and ISO 13485 design control (21 CFR 820.30) and risk management (ISO 14971) requirements. Lead material/design/process changes through a design control process, with well ... - Jun 20
Territory Manager (Boston/Metro West)
Inspire Medical Systems I
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Boston, MA
... We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Our focus on patient outcomes is at the core of everything we do, and ... - Jun 20