Regulatory Affairs Jobs in Irvine
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Katalyst Healthcares & Life Sciences-Irvine
agencies (Primarily US FDA).
Assess the appropriate regulatory reporting mechanism using FDA regulations, guidance documents, and in-house policies upon review of Change Control Documentation.
Work closely with Regulatory Affairs, Quality Assurance...
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B. Braun Medical Inc-Irvine
projects.
Responsibilities: Essential Duties
• Collaborate with QC, R&D, and Regulatory Affairs to identify products, testing criteria and type of stability studies required.
• Author stability protocols prior to the initiation of the stability study...
Katalyst Healthcares & Life Sciences-Irvine
Responsibilities:
Reviews product labelling for accuracy and for other legal/regulatory requirements and communicates planned/approved changes with other functions, including but not limited to operations, medical affairs and commercial teams...
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B. Braun Medical Inc-Irvine
Collaborate with QC, R&D, and Regulatory Affairs to identify products, testing criteria and type of stability studies required.
• Author stability protocols prior to the initiation of the stability study.
• Compile analytical data into stability reports...
Mindlance-Irvine
skills
Purpose Statement:
" The Regulatory Affairs Specialist supports the development and implementation of the global regulatory strategy for SkinMedica products. With supervision, the specialist reviews, plans and prepares regulatory documents...
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Irvine
General knowledge of GMP and GLP procedures.
• Advanced degree in life science, biochemistry, or equivalent with 2-5 years of relevant experience.
Preferred:
• Experience with bioreactors; AAV and TFF
• Familiarity with regulatory affairs...
uci.edu -
Katalyst Healthcares & Life Sciences-Irvine
and written communication skills.
Thorough knowledge of policies, practices and procedures related to Regulatory Affairs....
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Aliso Viejo, 12 mi from Irvine
Regulatory Affairs will be responsible for supporting and assisting the Regulatory Affairs Manager and/or Head of Regulatory Affairs Regional (whichever is applicable) to coordinate staff to meet the business needs.
Primary responsibilities include...
icims.com -
Katalyst Healthcares & Life Sciences-Irvine
Responsibilities:
Must Have MDR experience. IVD (In-vitro Diagnostics) is highly preferred.
Support the IVDR project by revising the assigned technical files. Each technical file must be generated using the latest technical file template and it...
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Katalyst Healthcares & Life Sciences-San Clemente, 24 mi from Irvine
Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions.
May serve as a lead regulatory representative to an assigned product or project team.
Review and approve critical documents, seeking guidance...
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