Regulatory Affairs Jobs in South Plainfield
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Search Results - Regulatory Affairs Jobs in South Plainfield
Katalyst Healthcares & Life Sciences-South Plainfield
Responsibilities:
The Regulatory Affairs Specialist II will support the IA business unit in meeting global registration requirements.
As a regulatory process expert supporting global registrations the candidate interprets federal/state...
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Katalyst Healthcares & Life Sciences-South Plainfield
Responsibilities:
The Regulatory Affairs Specialist coordinates, facilitates, and reports on post-market regulatory programs. Support the IA business units in meeting global registration requirements.
As a regulatory process expert supporting...
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Katalyst Healthcares & Life Sciences-South Plainfield
to the development and implementation of applicable work processes and instructions. Ensure they are kept up to date and implemented.
Maintains advanced and current knowledge of relevant regulations, policies, and guidelines and acts as Regulatory Affairs Subject...
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Katalyst Healthcares & Life Sciences-South Plainfield
M.S. in a technical area is helpful.
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
8 years experience in a regulated industry (e.g. medical devices, pharmaceuticals).
Individuals with "hands-on /authoring...
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Katalyst Healthcares & Life Sciences-South Plainfield
Responsibilities and Requirements:
Support daily Regulatory Affairs function eg; compliance to 21 CFR (phone number removed) ISO 13485 requirements, Company policies, operating procedures, processes, promotional task assignments into windchill...
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Katalyst Healthcares & Life Sciences-South Plainfield
Bachelor's degree required; advanced scientific degree preferred (Masters, PhD, PharmD, BSN, etc.) with 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience.
Experience in successfully leading teams; ability...
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Katalyst Healthcares & Life Sciences-South Plainfield
Job Description:
Qualifications:
• Bachelor's degree in Quality Management, Regulatory Affairs, Life Sciences, or a related field.
• Minimum of 5 years of experience in QMS, quality assurance, regulatory compliance, or related roles.
• Software...
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Katalyst Healthcares & Life Sciences-South Plainfield
with FDA.
Requirements:
Ph.D., M.D., PharmD., MS or commensurate experience. Significant experience in regulatory affairs (e.g., 3-5 years).
Expert understanding of policy, laws, regulations, and guidelines as they apply to U.S. FDA for drug development...
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Katalyst Healthcares & Life Sciences-South Plainfield
routinely and will develop a strong team environment with colleagues throughout GRS.
Education & Experience:
Ph.D., M.D., PharmD., MS or commensurate experience.
Significant experience in regulatory affairs (e.g., 3-5 years).
Expert understanding...
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Katalyst Healthcares & Life Sciences-South Plainfield
process
Work with Regulatory Affairs team members to acquire the required product approvals such as, U.L., FDA, C.S.A. and European product certifications.
You will have:
Bachelor's/ Masters degree in Mechanical Engineering with 8 - 13 years...
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