Medical Device Jobs in South Plainfield
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Search Results - Medical Device Jobs in South Plainfield
Katalyst Healthcares & Life Sciences-South Plainfield
network testing background like TCP/ IP & Packet capture (2-3 years minimum experience), Test cases designing and Deep understanding of System testing, python
Designs, implements, debugs, and executes software tests according to corporate
policies...
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Katalyst Healthcares & Life Sciences-South Plainfield
FDA Medical Device Reports (MDR), etc.) to determine trends and systemic issues. Prepare and issue reports based on information analysis.
Review existing investigation reports and identify gaps for GMP compliance.
Develop strategies and plans...
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Katalyst Healthcares & Life Sciences-South Plainfield
This role is a combo device position, the consultant is required to have experience with prefilled syringes, Class II/III devices, and sterilization.
There are 3 medical device products, one is already on the market, one will be approved...
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Katalyst Healthcares & Life Sciences-South Plainfield
Responsibilities and Requirements:
Education: Bachelor of Science in Engineering, B.E. / B.Tech. Mechanical Engg. / M.S. Mech. Engg.
4+ years relevant experience in Medical Device Manufacturing.
Clean room environment experience
Experience...
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Katalyst Healthcares & Life Sciences-South Plainfield
experience within a pharmaceutical and/or medical device company, or similar organization is required.
Ability to manager 5+ studies at a time is required.
Experience with different clinical phases.
Knowledge of clinical trial methodology and study design...
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Katalyst Healthcares & Life Sciences-South Plainfield
design and development.
Experience working with a Pharmaceutical, Biotech or Medical Device organization.
Experience working in an agile delivery environment. Ability to handle multiple priorities and work under pressure. Professional communications...
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Katalyst Healthcares & Life Sciences-South Plainfield
with a Pharmaceutical, Biotech or Medical Device organization.
Experience working in an agile delivery environment. Ability to handle multiple priorities and work under pressure. Professional communications skills is a must.
Good functional knowledge of Life Sciences...
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Katalyst Healthcares & Life Sciences-South Plainfield
and emerging requirements and quality trends as they relate to Pharmaceuticals, Medical Devices, and Combination Products worldwide.
Executes changes to quality processes to ensure conformance and continuous improvement.
Work with management and department...
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Katalyst Healthcares & Life Sciences-South Plainfield
effective execution for new innovative consumer-centric products and the life cycle management of products in the portfolio across the following regulatory classes (OTC monograph drugs, dietary supplements, cosmetics, foods, and medical devices) .
Monitor...
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Katalyst Healthcares & Life Sciences-South Plainfield
Coordination with manufacturing, regulatory, quality, and other key stakeholders as required to drive execution of supply strategy to maintain customer service levels.
Medical Device background in Industry required.
Strong Skills on organization, planning...
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Katalyst Healthcares & Life Sciences-South Plainfield
Responsibilities:
Bachelor's degree (B.S.) in related field or equivalent.
Five year's related experience or equivalent in a Medical Device or FDA Regulated industry.
Knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR...
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Katalyst Healthcares & Life Sciences-South Plainfield
in Chemistry / Analytical Chemistry is preferred).
Minimum 5-7 years of experience in medical device and/or pharmaceutical manufacturing or quality control environment.
Requirements:
Hands-on experience with methods utilizing DSC, Instron, spectrophotometers...
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Katalyst Healthcares & Life Sciences-South Plainfield
preferred).
9 years' industry experience in CDM in all study phases and activities from startup to archival with at least 5 years in lead role for clinical development programs with medical devices leading toward FDA filing / approvals.
Thorough knowledge...
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Katalyst Healthcares & Life Sciences-South Plainfield
understanding of pharma GxP environment and enabling emerging technologies for GxP.
Compliance Knowledge in establishing standards such as ISO 13485, ISO 9001 & ISO14971 guidelines for Pharmaceuticals, Biopharma and Medical devices in IT service industry...
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Katalyst Healthcares & Life Sciences-South Plainfield
level. Professionals with technical skills stated below but less relevant experience may be considered for ASSOCIATE level Regulatory Affairs.
Work experience with medical devices, pharmaceuticals and/or in-vitro diagnostic fields.
Previous regulatory...
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