Regulatory Specialist II
2 weeks ago
Role: Regulatory Specialist II
Location: Alameda, CA - 94502
Job Description:
- 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.
-
Regulatory Specialist II
3 weeks ago
Alameda, United States Intellectt Inc Full timeRole: Regulatory Specialist IIDuration: 6 months with possible extensionLocation: Alameda, CAExperience: 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:...
-
Regulatory Specialist II
4 weeks ago
Alameda, United States GForce Life Sciences Full timeJob Title: Regulatory Affairs Specialist II 100% on-site in Alameda, CA Must be able to work on a W2 6-month contract Job Summary:The Regulatory Affairs Specialist will be responsible for preparing and managing regulatory submissions to USFDA and OUS regulatory authorities, with a focus on medical devices and digital health technologies. The role involves...
-
Regulatory Specialist II
4 weeks ago
Alameda, United States Intellectt Inc Full timeRole: Regulatory Specialist IILocation: Alameda, CA- 94502Duration: 12 MonthsSkills Looking ForOngoing regulatory submissions and document management for medical devices in APAC countries.Handling changes and assessments based on country-specific regulations.5+ years of experience in medical device regulatory submissions.APAC submission writing experience,...
-
Regulatory Specialist II
3 weeks ago
Alameda County, United States Intellectt Inc Full timeRole: Regulatory Specialist IILocation: Alameda, CA - 94502Duration: 5 MonthsJob Description:Years Experience: 2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs functionSkills: Knowledge of regulations and standards affecting IVDs and/or...
-
Regulatory Specialist II
2 weeks ago
Alameda, United States Collabera Full timeJob DescriptionJob DescriptionList 3-5 hard requirements for the role:Experience in Regulatory submissions to USFDA and OUS Regulatory Authorities.US Medical device and software regulations background, NO Pharma only Medical Device.Strong verbal and written communications with ability to effectively communicate with cross functional teams in the...
-
APAC Regulatory Compliance Lead
3 weeks ago
Alameda, California, United States Collabera Full timeJoin Our TeamCollabera offers a competitive salary package for this Regulatory Specialist II role, estimated to be around $120,000 per year. As a key member of our team, you will contribute to the company's growth and success while developing your skills and expertise in regulatory affairs.Your responsibilities will include planning and executing tasks...
-
Regulatory Compliance Expert
2 days ago
Alameda, California, United States Collabera Full timeJob DescriptionCollabera, a global digital solutions company, seeks a highly skilled Regulatory Specialist II to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with country-specific regulations and standards.We are looking for a professional with experience in APAC regulatory submissions,...
-
Regulatory Specialist
3 weeks ago
Alameda, California, United States Collabera Full timeJob OverviewWe are seeking a highly skilled Regulatory Specialist to join our team at Collabera. This individual will be responsible for managing regulatory activities, including product registrations and impact assessments.The ideal candidate will have a strong understanding of country-specific requirements and be able to communicate effectively with...
-
Regulatory Specialist II
2 weeks 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,...
-
Alameda, California, United States Abbott Laboratories Full timeAbout Abbott\Abbott 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...
-
Regulatory Compliance Specialist
3 weeks ago
Alameda, California, United States Collabera Full timeJob OverviewCollabera is seeking a highly skilled Regulatory Compliance Specialist to join our team in the role of Medical Device Regulatory Expert. This position requires strong knowledge of APAC country regulations, including TGA, NMPA, PMDA, MFDS, HSA, TFDA, FDA, MOH.The successful candidate will have experience in regulatory activities, including product...
-
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...
-
Senior Regulatory Affairs Specialist
1 week 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...
-
Regulatory Affairs Specialist
2 days ago
Alameda, California, United States Exelixis Full timeAbout the RoleExelixis is seeking a talented Regulatory Affairs Specialist to join our team. In this role, you will play a key part in the development and submission of regulatory documents, ensuring compliance with relevant regulations and guidelines.Key ResponsibilitiesDevelop and prepare regulatory documents, including CSRs, CTD summaries, and...
-
Senior Regulatory Affairs Specialist
4 days 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...
-
Regulatory Compliance Specialist
4 days ago
Alameda, California, United States Abbott Full timeAbout the Role">We're seeking a Regulatory Compliance Specialist to lead the implementation and improvement of our CAPA process and electronic system within our Quality Management System. As a member of our team, you'll be responsible for ensuring compliance with FDA regulations, providing guidance and training to the team and business on quality standards...
-
Alameda, California, United States Abbott Laboratories Full timeAbout Abbott LaboratoriesAs a global healthcare leader, Abbott Laboratories 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.The OpportunityWe're seeking a skilled...
-
Regulatory Affairs Specialist
4 weeks ago
Alameda, United States The Fountain Groups Full time100% ONSITE IN ALAMEDA CA PAY: $56-$60/HR REQUIRED:BS in Regulatory Affairs, Science or Engineering and 2-5 years of experience with the following:List 3-5 hard requirements for the role:Experience in Regulatory submissions to USFDA and OUS Regulatory Authorities.US Medical device and software regulations background, NO Pharma only Medical Device.Strong...
-
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...
-
Regulatory Compliance Specialist
3 weeks ago
Alameda, California, United States Collabera Full timeJob DescriptionThis is a key role within our organization, focusing on regulatory compliance and ensuring that our medical devices meet the necessary requirements.We are seeking an experienced professional with a strong background in US FDA and OUS regulatory submissions, as well as a solid understanding of software regulations for medical devices.The...