| Job alert | Jobs 51 - 60 of 837 |
Principal Regulatory Specialist
Amplitude Vascular Systems
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Boston, MA, 02298
... Experience with FDA IDE and PMA submissions. Knowledge/skills/Abilities: Knowledgeable of FDA (21CFR 812, 820), ISO 13485, and ISO14971 Thorough understanding of FDA and applicable international regulations. Excellent written and oral communication, ... - May 13
Clinical Research Associate
Anteris Tech
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Boston, MA
... Experience with site- and sponsor-level FDA BIMO investigation(s) Excellent written and verbal communication, presentation, interpersonal, and analytical skills required. Experience working with CROs, core labs and other external vendors ... - May 22
Chief Technical Officer (Small Molecule)
Kennedy Bond
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Boston, MA, 02298
... Ensure quality oversight for FDA readiness, oversee tech transfer, batch record review, validation, comparability studies, fill finish, change control, etc.; Ensure timely delivery of drug substance and drug product for discovery initiatives; ... - May 23
Quality Assurance Manager
Veritas Search Group
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Boston, MA, 02298
... - Oversee change controls, complaints, investigations, CAPAs, IQ/OQ/PQ protocols and reports, specifications, and stability protocols to ensure compliance with regulatory requirements (FDA/ICH/ISO). - Review and approve lot analytical methods, ... - May 19
Quality System Associate
Meridian Bioscience, Inc.
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North Billerica, MA
... Ensure compliance with the organization’s policies and all applicable national (FDA 21 CFR Part 820) and international quality standards and regulations (i.e. ISO) regarding Documentation Control. Work with R&D, Manufacturing, Product Support and ... - May 16
Senior Human Factors Engineer
Embecta
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Andover, MA
... Human Factors evidence of successful use-related risk mitigation specific to the device and its development (for both FDA and CE mark) EXPERIENCE & EDUCATION: * Bachelor's Degree in a technical field related to Human Factors Engineering (human ... - May 08
Senior Software Engineer
Cytrellis Biosystems
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Woburn, MA, 01801
... What makes Cytrellis different: ️ Unique product offering – ellacor by Cytrellis is the FIRST and ONLY FDA-cleared device for non-surgical, scarless skin removal. ️ Untapped Market Potential: 5x account growth in the last 8 months ️Voted Best Non ... - May 03
Senior Mechanical Engineer
Cytrellis Biosystems
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Woburn, MA, 01801
... What makes Cytrellis different: ️ Unique product offering – ellacor by Cytrellis is the FIRST and ONLY FDA-cleared device for non-surgical, scarless skin removal. ️ Untapped Market Potential: 5x account growth in the last 8 months ️Voted Best Non ... - May 15
Principal Scientist
Johnson & Johnson
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Danvers, MA, 01923
... and approval, including consensus building with study steering committee and principal investigators and communication with FDA * Work closely with biostatistics team to evaluate study design options and analyze study data to support study decisions ... - May 27
HVAC Technician
Mentor Technical Group
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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 17