in Vitro Diagnostics Jobs in Alameda (CA)
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Abbott Laboratories-Alameda (CA)
monitoring, clinical trial practices and regulations.
• Experience in conducting medical device and/or in-vitro diagnostics studies. Pharmaceutical background may also be considered.
• Demonstrated excellence in teamwork, shared mindset for success...
Abbott Laboratories-Alameda (CA)
for product labels, cartons, and other related materials ensuring that they meet all medical, legal, and regulatory requirements for medical devices/in vitro diagnostic devices (IVDs) following the established creative design format and brand guidelines...
jobs.abbott -
Abbott Laboratories-Alameda (CA)
EXPERIENCE YOU’LL BRING
Required:
• Bachelors Degree
• Minimum 8 years of Quality Systems, Quality Assurance and/or Regulatory Compliance/Affairs experience in In Vitro Diagnostics and medical device manufacturing or other similarly regulated environment...
Randstad Life Sciences US-Menlo Park (CA), 23 mi from Alameda (CA)
associated forms and other documents as part of Standard Operating Procedures and Work Instructions process requirements, in compliance with the EU In Vitro Diagnostic Regulation (IVDR), ISO 13485, ISO 14971, FDA 21 CFR 820 and related medical device...
mindmatch.ai -
Abbott Laboratories-Alameda (CA)
and industry standards for medical device development and in vitro diagnostic device (IVD) including but not limited to ISO 13485, ISO 14971, and FDA Guidance for medical device development.
• Experience in performing complex engineering calculations...
HCL America, Inc.-Santa Clara, 34 mi from Alameda (CA)
and documentation requirements. Knowledge of global medical device regulatory requirements. Support clients in getting marketing authorization of Invitro diagnostic devices to European and global markets to ensure continued availability of safe and essential...
jobvertise.com -
Abbott Laboratories-Alameda (CA)
devices/in vitro diagnostic devices (IVDs) following the established creative design format and brand guidelines
• Complies with U.S. Food and Drug Administration (FDA) regulations, other global regulatory requirements, company policies, operating...
Complete Genomics-San Jose, 34 mi from Alameda (CA)
for the QMS development, implementation, and maintenance to comply with applicable Quality System Regulations, In Vitro Diagnostic Regulations (IVDR) and ISO standards.
WHAT YOU WILL BE DOING
• Leads the quality department.
• Manages processes and teams...
mindmatch.ai -
Experis-South San Francisco, 11 mi from Alameda (CA)
Invitro Diagnostic (IVD) Products within our Design Engineering team.
• Ensure that all applicable Medical Device Regulations for Complaint Handling are incorporated within local SOPs and work instructions and followed.
• Developing and maintaining...
Abbott Laboratories-Pleasanton (CA), 24 mi from Alameda (CA)
in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices.
• Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).
Preferred...
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