| Job alert | Jobs 1 - 10 of 749 |
Senior Manufacturing Engineer
Engtal
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Boston, MA, 02298
... Ensure compliance with ISO 13485, FDA regulations, and GMP standards. Provide technical leadership and mentorship to junior engineers. Qualifications: Bachelor’s in Mechanical, Manufacturing, or Industrial Engineering (Master's preferred). 7+ years ... - Sep 12
Vice President Regulatory Affairs
Scienta
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Boston, MA, 02298
... innovative biotech products Global Regulatory Submissions: Oversee the preparation, submission, and management of regulatory applications including INDs, NDAs, BLAs, MAAs, and other relevant filings across multiple regions (FDA, EMA, PMDA, etc.). ... - Sep 06
Senior Quality Engineer
Engtal
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Boston, MA, 02298
... Ensure full compliance with FDA, ISO 9001, ISO 13485, and GMP regulations. Investigate non-conformances and manage CAPA processes, performing root cause analysis and corrective/preventive actions. Collaborate closely with R&D, manufacturing, and ... - Sep 12
Lead Calibration Technician
Micro Tech Staffing - Stoughton
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Boston, MA
75000USD - 90000USD per year
... Looking for candidates with: Experience in an FDA regulated environment Conducting routing testing and calibration of equipment per work instructions Prepare reports including Work orders, IQs, and more Writes calibration procedures, prepares ... - Sep 05
Senior CSV Engineer
LS Solutions
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Boston, MA, 02298
... Experience authoring/editing/executing validation documents for laboratory equipment • Working knowledge of FDA regulations, ISPE guidelines and ISO standards including: Good Documentation Practice (GDP) in pharmaceutical environment 21 CFR Part 11 - Sep 22
Regulatory Affairs Co-Op/Intern
Nova Biomedical
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Waltham, MA, 02454
... The RA Intern will provide pre-market and post-market regulatory support to US FDA, Health Canada, EU, and other International Regulatory Licensing and Registration Agencies. Other responsibilities include: Support Self-Certified and Notified Body ... - Sep 18
Clinical Project Manager
Albion Rye Associates
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Boston, MA, 02298
... Ensure adherence to clinical trial plans and regulatory guidelines (FDA, EMA, ICH/GCP). Vendor & CRO Oversight: Manage relationships with CROs, clinical sites, and other vendors to ensure quality, timelines, and compliance. Monitor vendor ... - Sep 22
Import Export Coordinator
SSi People
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Cambridge, MA, 02140
... (Oracle module) Provide import clearance instructions to broker by validating and preparing documentation subject to Customs, FDA and other government agencies Point of contact for shipment processing with different business partners and respond to ... - Sep 13
Account Executive, Point of Care - New England
Nova Biomedical
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Boston, MA, 02111
... Product portfolio includes Nova’s StatStrip – Only glucose meters accurate enough to be FDA-cleared for use with all patients, including critically ill. We offer competitive base salary, uncapped commission, company car and many other comprehensive ... - Sep 17
Clinical Research Associate III
ACE Partners
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Boston, MA, 02298
... Familiarity with US FDA CFR and relevant guidelines for conducting clinical trials (e.g., GCP certification or equivalent) Leadership / mentorship experience. - Sep 01