| Job alert | Jobs 51 - 60 of 636 |
Senior iOS Developer
TransMedics, Inc.
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Andover, MA
... Demonstrated experience working on software that integrates with medical devices subject to FDA regulation and data subject to HIPAA regulations. Knowledge of and experience working with the CoreBluetooth Framework and Bluetooth LE connections. ... - Apr 19
Hybrid Regulatory Intern
Withings
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Boston, MA
The Regulatory Affairs Intern will support the Regulatory Affairs team in daily tasks, projects, and FDA submission activities including: Assist in drafting, organizing, and editing regulatory documents for 510(k) submissions. Coordinate workflow ... - May 09
Material Control Coordinator
Finish Line Staffing Services
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Wilmington, MA
... adhere to safety standards established by FDA and other regulatory agencies Ability to work in changing environments (reduced lighting, increased noise, temperature variances, unpleasant odors, etc.) The shift hours are 9:00 a.m.-5:30 p.m. - Apr 25
Automation Engineer (DeltaV)
LVI Associates
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Boston, MA, 02298
... With extensive experience in cGMP and FDA regulated industries, our team of engineers delivers innovative automation solutions aligned with industry standards. We provide professional support and expertise in Automation, Manufacturing Systems, and ... - May 13
Quality Systems Analyst
Resonetics
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Nashua, NH
... Ensure work is performed in compliance with regulatory standards (e.g., FDA, ISO 13485, 21 CFR Parts 820 and 11) and internal quality requirements. Build dashboards and reports to monitor the effectiveness of the QMS. Conduct risk assessments and ... - May 10
Senior Quality Auditor
RBW Consulting
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Boston, MA, 02298
... Reporting to the Head of Quality, our client seeks a candidate with several years of experience as a qualified auditor (cGMP, QSR, ICH) in life sciences, with a strong knowledge of FDA and global regulations/guidelines. A successful candidate needs ... - May 02
Senior Clinical Trial Leader
Kura Oncology
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Boston, MA
... Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations. Ability to travel up to approximately 30% of time. Hybrid on-site in Boston two days per week. WORK ENVIRONMENT: Employee frequently works in a professional office environment ... - Apr 30
SAFETY & PHARMACOVIGILENCE SPECIALIST
Beacon Hill
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Cambridge, MA, 02140
... research including: adverse event analysis and processing, serious adverse event reconciliation • Preparation of IND safety reports for submission to the FDA • Safety document or data analysis • Clinical trial site support REQUIREMENTS • M.D. ... - Apr 27
Program Manager Product Development
TransMedics, Inc.
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Andover, MA
... REQUIREMENTS: 8+ years of experience working in an FDA/ISO regulated medical device/medical equipment environment. 5+ years of experience preferred managing technical teams and programs. Detail oriented with strong organizational skills. Strong ... - Apr 20
Head of Regulatory Affairs
Discera Search
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Boston, MA, 02298
... Demonstrate resilience and assertiveness in interactions with the FDA, advocating for our innovative therapies and proactively addressing regulatory challenges to ensure timely approval and market access. Facilitate communication with the FDA, ... - May 01