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FDA jobs in Boxford, MA

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Product Development Engineer (R&D)

Intellectt INC  –  Billerica, MA
... In-depth knowledge of FDA regulations, ISO 13485, and other relevant quality standards. Domain experience with process engineering/transfer to contract manufacturing preferred. Lean Six Sigma background ideal, enabling/optimizing ideal yields ... - May 29

Regulatory Affairs Manager

Genabio Diagnostics  –  Bedford, MA, 01730
Qualifications: degree or above in a relevant discipline required years of industrial experience in IVD or medical device FDA registration in Chinese preferred Tasks: and support new product 510k Submissions and support International Device ... - May 13

Process Development Engineer II

Planet Pharma  –  Billerica, MA, 01821
... Comply with applicable FDA and international regulatory laws/standards. Perform other duties as assigned or required. Nice to Have 2+ years of experience developing products and/or manufacturing processes in the medical device industry Knowledge of ... - May 26

Director of Quality Assurance

Walker Cole International  –  Boston, MA, 02298
... leading FDA inspection readiness activities Exceptional communication skills oral and written QA Quality Assurance Quality Control cGMP AAV Gene Therapy CDMO Biologics Manufacturing Quality Operations Quality Systems FDA CGT Cell and Gene Therapy - May 15

Director, Non-Clinical Toxicology

MapLight Therapeutics, Inc.  –  Burlington, MA, 01805
... EU, Japan, and International regulatory meetings and filings Respond with scientifically robust rationale to questions from US FDA, EU, Japan, and other health authorities in support of development programs Collaborate with CMC, Program & Portfolio ... - May 18

Associate Director Quality Systems

Monte Rosa Therapeutics, Inc  –  Boston, MA
... Knowledge and experience of clinical and commercial systems supporting compliance with US and global regulations (FDA, EMA, ICH, etc.). GLP experience a plus. Able to provide solution-minded approach and flexibility to emerging challenges. Able to ... - May 29

Engineer: Manufacturing

Nanobiosym  –  Cambridge, MA
... Develops and implements validation protocols (IQ/OQ/PQ) that comply with FDA regulations. Conducts root cause analysis of product quality issues. QUALIFICATIONS S. or B.S. in Engineering (Plastics or Mechanical preferred) Six Sigma Black Belt, a ... - May 04

Medical Supply Delivery and Installation Technician

Cardinal Health  –  Peabody, MA
... Will satisfactorily complete training and be responsible for Cardinal Health compliance and regulations concerning OSHA, DEA, FDA, State and local authorities * Support and contribute in the development and implementation of innovative modifications ... - May 31

Aesthetic Clinical Trainer

Cytrellis Biosystems  –  Fenway, MA, 02115
... 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 29

X-ray FSE

Cephas Consultancy Services Private Limited  –  Boston, MA
... Completion of all necessary state and FDA required paperwork associated with the installation of radiation generating equipment. Ordering of parts and supplies required to maintain equipment and tickets assigned. Maintains a working knowledge and ... - May 15
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