Regulatory Specialist II
3 days ago
Exempt/Non Exempt: Non Exempt Years Experience: 2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs function Skills: Knowledge of regulations and standards affecting IVDs and/or biologics Education: BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.Duties: Responsible for implementing and maintaining the effectiveness of the quality system. Supports manufacturing/operations day to day activities for change control. Provides consultation/advice to regulatory specialist for change control and product development. Provides regulatory direction/interpretation on team activities. Interprets and applies regulatory understanding to support of products and teams. Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide. Handles regulatory activities involved in documentation,labeling,field support. Applies regulatory and technical knowledge to a wide variety of complex work assignments. Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports. Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.
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Regulatory Specialist II
1 month ago
Alameda, United States Planet Pharma Full time614462Our client, a leading Medical Device company in Alameda, CA, is looking for a Regulatory Affairs Specialist II to provides consultation/advice to regulatory specialist for change control and product development.Required Skills:2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality,...
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Regulatory Specialist II
1 week ago
Alameda, United States Manpower Group Inc. Full timeOur client, the medical device manufacturing industry, is seeking a Regulatory Specialist II to join their team. The ideal candidate should be strong in analytical skills, knowledge about requirements for APAC specifically, ability to manage projects, and time management. Job Title: Regulatory Specialist Location: Alameda , CA Pay Range: $50-$55/hr on...
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Regulatory Specialist II
3 days ago
Alameda, United States Experis Full timeOur client, the medical device manufacturing industry, is seeking a Regulatory Specialist II to join their team. The ideal candidate should be strong in analytical skills , knowledge about requirements for APAC specifically, ability to manage projects, and time management. Job Title: Regulatory Specialist Location: Alameda , CAPay Range: $50-$55/hr on...
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Regulatory Specialist
2 weeks ago
Alameda, United States Spectraforce Technologies Full timeTitle: Regulatory Specialist IIDuration: 1 year with the possibility of extensionLocation: Alameda CA 94502Experience Background (Any): APAC regulatory submissions in Medical Devices or Pharmaceutical industries.Experience: 2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or...
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Regulatory Expert for Global Compliance
1 week ago
Alameda, California, United States Collabera Full timeCollabera is a leading digital solutions provider, serving the world's most innovative organizations in technology, finance, telecom, and healthcare. We are seeking a highly skilled Regulatory Specialist II to join our team.As a key member of our global regulatory compliance team, you will be responsible for managing product registrations, conducting impact...
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Regulatory Specialist II
2 months ago
Alameda, United States Collabera Full timeJob DescriptionJob Description· List 3-5 hard requirements for the role: Responsible for regulatory activities, including product registrations, impact assessment, etc.· Understand country-specific requirements and deliver those to internal stakeholders, including product management, engineering, labeling, etc., for product...
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Alameda, California, United States Abbott Laboratories Full timeAbout Us">At Abbott Laboratories, we're a global healthcare leader committed to helping people live more fully at all stages of life. Our diverse portfolio spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.">About the Role">We're seeking an experienced...
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Regulatory Specialist II
2 months ago
Alameda, United States Collabera Full timeJob DescriptionJob Description· Education: Bachelor’s degree· Experience Background (Any): APAC regulatory submissions in Medical Devices or Pharmaceutical industries. Job Description (Expectation):· Responsible for regulatory activities, including product registrations, regulatory impact assessment,...
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Regulatory Compliance Specialist
7 days ago
Alameda, California, United States Collabera Full timeJob SummaryWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at Collabera. As a key member of our regulatory department, you will be responsible for ensuring compliance with regulatory requirements in the APAC region.About UsCollabera is a global digital solutions company providing software engineering solutions to top...
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Alameda, California, United States Abbott Laboratories Full timeAbout Abbott LaboratoriesAbbott Laboratories is a leading global healthcare company that empowers people to live their best lives. With a diverse portfolio of life-changing technologies, we deliver innovative solutions across diagnostics, medical devices, nutritionals, and branded generic medicines.Salary RangeThe estimated annual salary for this position is...
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Digital Regulatory Affairs Strategist
1 week ago
Alameda, California, United States Abbott Laboratories Full timeAbout AbbottAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160...
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Alameda, United States Abbott Full timeThe Opportunity The Principal RA Specialist – US New Product Introduction will work on-site out of our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way...
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Complaint Handling Specialist II
1 month ago
Alameda, United States Abbott Full timeThe Opportunity The Complaint Handling Specialist II will be responsible for the following: Accurately evaluate, review, assess, and process complaints in a uniform and timely manner. Evaluate complaint documentation and investigation information to determine what level of further investigation, if any, is required to determine a possible failure...
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Data Analyst II
3 days ago
Alameda, United States The Fountain Group Full timeThe Fountain Group is a national staffing firm and we are currently seeking a Data Analyst II for a prominent client of ours. This position is in Alameda, CA 94502. Details for the position are as follows: Job Description: $47 - $50/hour Support the CX team managers US Customer Service is a large cross-functional department. This role would be onsite, and...
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Alameda, California, United States Collabera Full timeJob OverviewWe are seeking a highly skilled Regulatory Affairs Associate to join our team at Collabera.This role will involve working closely with cross-functional teams to manage regulations and ensure compliance with government requirements.Key ResponsibilitiesManage regulations and work with cross-functional teams to ensure complianceAnalyze and...
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Complaint Handling Specialist II
1 month ago
Alameda, United States Abbott Laboratories Full timeAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.Working at...
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Grievance and Appeals Coordinator II
1 week ago
Alameda, United States Allameda Alliance for Health Full timePRINCIPAL RESPONSIBILITIES: Under general direction of the Grievance and Appeals Leadership, the Grievance and Appeals (GandA) Coordinator II will review, investigate and process non-complex grievances for all lines of business and the completion of written communication documents to convey determination. The Coordinator is responsible for processing and...
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Grievance and Appeals Coordinator II
1 week ago
Alameda, United States Alameda Alliance for Health Full timePRINCIPAL RESPONSIBILITIES: Under general direction of the Grievance and Appeals Leadership, the Grievance and Appeals (G&A) Coordinator II will review, investigate and process non-complex grievances for all lines of business and the completion of written communication documents to convey determination. The Coordinator is responsible for processing and...
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Grievance and Appeals Coordinator II
1 week ago
Alameda, United States Alameda Alliance for Health Full timeDescriptionPRINCIPAL RESPONSIBILITIES: Under general direction of the Grievance and Appeals Leadership, the Grievance and Appeals (G&A) Coordinator II will review, investigate and process non-complex grievances for all lines of business and the completion of written communication documents to convey determination. The Coordinator is responsible for...
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Alameda, California, United States Exelixis Full timeJob Summary: Exelixis is seeking an experienced Clinical Pharmacologist II to join our team. The ideal candidate will have a strong background in pharmacology, experience with modeling and simulation, and excellent communication skills.About the RoleDevelop and implement clinical pharmacology strategies to drive drug candidates through development...