Regulatory Affairs Specialist
2 weeks ago
Infojini Consulting is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will play a critical role in ensuring compliance with EU IVD regulations and supporting the preparation of regulatory submissions.
Key Responsibilities:- Assist in the preparation of regulatory submissions, including IVDR technical dossiers, for CE Mark approval.
- Coordinate with partner channel regulatory colleagues to obtain product approvals.
- Organize, update, and maintain regulatory documentation, including logs and trackers.
- Request and track document legalization, apostille, and certificates from regulatory agencies.
- Process change orders for approval of documentation in electronic records management systems.
- Perform other related duties and responsibilities as assigned.
- Bachelor's degree in a relevant field, preferably Science or Engineering.
- Excellent understanding of EU IVD regulation.
- Strong verbal and written communication skills, with attention to detail.
- Ability to multitask, prioritize, and meet deadlines in a timely manner.
- Strong organizational skills, with the ability to handle multiple assignments simultaneously.
- Excellent verbal communication skills, with the ability to effectively communicate at multiple levels in the organization.
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Regulatory Affairs Specialist
4 weeks ago
Fremont, California, United States Infojini Consulting Full timeRegulatory Affairs SpecialistInfojini Consulting is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will play a critical role in ensuring the compliance of our medical devices with EU IVD regulations.Key Responsibilities:Assist in the preparation of regulatory submissions for IVDR...
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Regulatory Affairs Specialist
15 hours ago
Fremont, California, United States Yoh Full timeRegulatory Affairs Associate IYoh is seeking a highly motivated and detail-oriented Regulatory Affairs Associate I to join our team. As a Regulatory Affairs Associate I, you will assist in preparing responses to global information requests and related maintenance documentation, determine regulatory strategies for manufacturing changes and regulatory...
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Regulatory Affairs Specialist
2 weeks ago
Fremont, California, United States Yoh Full timeRegulatory Affairs Associate IYoh, a leading staffing company, is seeking a highly skilled Regulatory Affairs Associate I to join our team. As a key member of our regulatory team, you will play a critical role in ensuring compliance with global regulations and standards.Key Responsibilities:Assist in preparing responses to global information requests and...
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Regulatory Affairs Specialist
3 days ago
Fremont, California, United States US Tech Solutions Full timeJob Title: Regulatory Affairs Associate IDuration: 08 Months Contract (Possible Extension)We are seeking a highly motivated and detail-oriented Regulatory Affairs Associate I to join our team at US Tech Solutions. As a key member of our regulatory team, you will play a critical role in ensuring compliance with global regulations and standards.Assist in...
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Regulatory Affairs Specialist
2 weeks ago
Fremont, California, United States Yoh, A Day & Zimmermann Company Full timeJob Title: Regulatory Affairs Associate IYoh, a Day & Zimmermann company, is seeking a highly skilled Regulatory Affairs Associate I to join our team. As a Regulatory Affairs Associate I, you will play a critical role in ensuring compliance with global regulations and cGMP requirements.Responsibilities:Assist in preparing responses to global information...
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Regulatory Affairs Specialist
2 weeks ago
Fremont, California, United States eTeam Full timeJob Title: Regulatory Affairs AssociateLocation: Fremont, CADuration: 20 MonthsShift Timing: 1st Shift: Mon-Fri, 8:00AM-5:00PMDuties:Assist in preparing responses to global information requests and related maintenance documentation (amendments, supplements, annual reports, safety reports, etc.) within a defined time schedule.Help determine regulatory...
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Regulatory Affairs Specialist
4 days ago
Fremont, California, United States Staffing Full timeJob OverviewWe are seeking a highly skilled Regulatory Affairs Associate to join our team. The successful candidate will be responsible for assisting in the preparation of responses to global information requests and related maintenance documentation.Key ResponsibilitiesAssist in preparing responses to global information requests and related maintenance...
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Regulatory Affairs Director
14 hours ago
Fremont, California, United States Scribe Therapeutics Full timeJob Title: Associate Director/Director, Regulatory AffairsScribe Therapeutics is a molecular engineering company focused on creating best-in-class in vivo therapies that permanently treat the underlying cause of disease. Our team is passionate about developing custom engineered enzymes and delivery modalities as part of a proprietary, evergreen CRISPR by...
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Regulatory Affairs Director
3 weeks ago
Fremont, California, United States Scribe Therapeutics Full timeJob Title: Associate Director/Director, Regulatory AffairsScribe Therapeutics is a molecular engineering company focused on creating best-in-class in vivo therapies that permanently treat the underlying cause of disease. Our team is dedicated to developing custom engineered enzymes and delivery modalities as part of a proprietary, evergreen CRISPR by...
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Principal Regulatory Affairs Specialist
21 hours ago
Fremont, California, United States Abbott Full timeThe OpportunityWe are seeking a highly skilled Principal Regulatory Affairs Specialist to join our team in the Diabetes Care Division at Abbott. As a key member of our regulatory team, you will play a critical role in ensuring the successful introduction of new products in the US market.Our team is responsible for developing and implementing regulatory...
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Principal Regulatory Affairs Specialist
4 weeks ago
Fremont, California, United States Abbott Full timeThe OpportunityAbbott is seeking a highly skilled Principal Regulatory Affairs Specialist to join our Diabetes Care Division in Alameda, CA. As a key member of our team, you will play a critical role in ensuring the regulatory compliance of our new product introductions in the US market.This is an exciting opportunity to work on breakthrough advancements in...
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Senior Regulatory Product Specialist
3 weeks ago
Fremont, California, United States Abbott Full timeThe OpportunityThis Senior International Regulatory Product Specialist will play a key role in the Diabetes Care Division at Abbott, working on-site at our Alameda, CA location. Our team is dedicated to helping people with diabetes manage their health with innovative products that provide accurate data for informed decisions. We're revolutionizing glucose...
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Fremont, California, United States Abbott Full timeThe OpportunityThis Senior International Regulatory Operations Specialist will join our team at Abbott's Alameda, CA location in the Diabetes Care Division. We're revolutionizing the way people manage their diabetes with innovative products that provide accurate data to drive better-informed decisions.As an individual contributor, the Senior Specialist will...
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Senior International Regulatory Product Specialist
2 months ago
Fremont, California, United States Abbott Full timeAbout the RoleWe are seeking a highly skilled Senior International Regulatory Product Specialist to join our Diabetes Care Division at Abbott. As a key member of our team, you will play a critical role in ensuring the efficient and compliant business processes and environment for our regulatory department.Key ResponsibilitiesAssist in the development and...
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Fremont, California, United States Abbott Full timeAbout the RoleThis Senior International Regulatory Product Specialist will be part of the Diabetes Care Division at Abbott, working on-site at our Alameda, CA location. We're a leading healthcare company focused on helping people with diabetes manage their health with innovative products that provide accurate data to drive better-informed decisions.Key...
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Clinical Regulatory Compliance Specialist
2 weeks ago
Fremont, California, United States Spectrum Health Full timeAbout Spectrum HealthSpectrum Health is a leading health system dedicated to delivering exceptional patient care and advancing the health of our communities. Our mission is to improve the health and well-being of the people we serve, and we are committed to providing a safe and inclusive environment for our patients, visitors, and team members.Job SummaryWe...
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Medical Affairs Operations Specialist
3 weeks ago
Fremont, California, United States Bayside Solutions Full timeJob SummaryAs a key member of our dynamic Medical Affairs team, you will assist several diverse business functions with purchasing system processes. This role requires a strong understanding of contract administration and procurement principles, as well as excellent communication and organizational skills.Duties and ResponsibilitiesManage and track Medical...
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Senior Regulatory Product Specialist
1 month ago
Fremont, California, United States Abbott Full timeAbout the RoleWe are seeking a highly skilled Senior International Regulatory Product Specialist to join our Diabetes Care Division at Abbott. As a key member of our team, you will play a critical role in ensuring the efficient and compliant business processes and environment for our regulatory department.Key ResponsibilitiesAssist in the development and...
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Administrative Operations Specialist
4 weeks ago
Fremont, California, United States Bayside Solutions Full timeJob SummaryWe are seeking a highly skilled Contracts and Administrative Operations Specialist to join our dynamic Medical Affairs team. As a key member of our team, you will assist various business functions with purchasing system processes.Key ResponsibilitiesManage and track Medical Affairs activities to ensure seamless execution.Execute agreements with...
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Administrative Operations Specialist
4 weeks ago
Fremont, California, United States Bayside Solutions Full timeJob SummaryWe are seeking a highly skilled Contracts and Administrative Operations Specialist to join our dynamic Medical Affairs team. As a key member of our team, you will assist various business functions with purchasing system processes.Duties and ResponsibilitiesManage and track Medical Affairs activities to ensure seamless execution.Execute agreements...