| Job alert | Jobs 71 - 80 of 845 |
Manager, Global Regulatory Affairs, Marketed Products
BioSpace, Inc.
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Boston, MA, 02298
... Regulatory submissions to US FDA, EU, Health Canada, and other international health authorities - Support regulatory team and Global Regulatory Lead (GRL) in preparations and timely delivery of detailed and accurate regulatory submissions for drugs, ... - May 26
Sr. Manager GCP quality Assurance
Planet Pharma
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Waltham, MA
... • Provide interpretation and guidance for internal and external customers on GCP related regulations/ guidelines (FDA, ICH, EU, etc.), including Risk Based Quality Management, and company procedures and policies. • Collaborate with internal and ... - May 19
Site Director
DM Clinical Research
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Boston, MA
... The site director will also ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations and ICH/GCP guidelines and to provide the best quality data to the sponsor. DUTIES & ... - May 31
Sr. Manager, Quality Compliance (NC/CAPA)
Integralife
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Gallows Hill, MA, 01970
... This role requires experience in the front room of external audits, and preferably experience with FDA inspections. This role will manage the CAPA program as well as be the site Quality reviewer and approver for CAPAs, including any addressing FDA ... - May 29
Sr. Cleaning Validation Engineer
a Medical Devices company in MA
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Bedford, MA, 01730
... RESPONSIBILITIES Minimum 8+ years of cleaning validation experience in pharmaceutical, medical device or FDA regulated environments. Strong understanding of cGMP and regulations related to facility, utility, equipment, and process validations. ... - May 14
Senior Specialist, Quality Assurance
PepGen
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Boston, MA, 02118
... The Sr Specialist ensures continued compliance with FDA and other applicable regulations. Responsibilities Provide Quality review for external production and testing activities for clinical trial material Review and assess deviations, including risk ... - May 31
ASSOCIATE BRAND MGR BRAND OPS AND ANALYTICS
HP Hood
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Lynnfield, MA, 01940
... The operations lead is responsible for working through any market/internal issue, such as pricing, FDA regulations, and supply chain, to ensure that any change will result in minimal impact to the brand. Essential Duties Responsibilities Serve as ... - May 24
Manufacturing Engineer
firstPRO, Inc
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Billerica, MA, 01821
... Knowledge of FDA QSR's and ISO regulations is helpful. Education/Experience: B.S in Mechanical Engineering/Biomedical/Electromechanical Engineering with 5-10 years of experience in the Biomedical or High Volume manufacturing field. Must have ... - May 18
Senior Human Factors & Usability Engineer
Fresenius Medical Care
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Lawrence, MA, 01842
... * Responsible for HF assessments included in regulatory documents submitted to the FDA (or other regulatory bodies). * Responsible for ensuring compliance to applicable standards and guidance. * Contributes to human factors process development and ... - May 20
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