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Regulatory Affairs Project Manager
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Santa Clara, California, United States Intellectt Inc Full timePosition: Regulatory Affairs Project ManagerCompany: Intellectt IncLocation: Santa Clara, CAJob Overview:Education: A Bachelor's degree is mandatory; a Master's degree is advantageous.Experience: At least 3 years of relevant experience is essential.Skills: Familiarity with US and/or Canadian regulations concerning product and/or device approval (FDA) is...
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Regulatory Affairs Project Manager
3 months ago
Santa Clara, United States GForce Life Sciences Full timeResponsibilities:Assist in various regulatory duties including completion of deliverables and preparation of regulatory submissions for the next-gen clip system.Develop an understanding of Clip products and manufacturing processes to review and assess proposed product changes within the change management system.Provide regulatory support for...
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Regulatory Affairs Project Manager
3 months ago
Santa Clara, United States GForce Life Sciences Full timeResponsibilities:Assist in various regulatory duties including completion of deliverables and preparation of regulatory submissions for the next-gen clip system.Develop an understanding of Clip products and manufacturing processes to review and assess proposed product changes within the change management system.Provide regulatory support for...
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Regulatory Affairs Project Leader
3 months ago
Santa Clara, United States Collabera Full timeJob DescriptionJob Description· Education: Bachelor's degree required, Master’s degree preferred· Experience: Minimum of 3 years of Regulatory Affairs experience· Skills: Knowledge of US and/or Canadian regulations or with EU and other international medical device regulations relating to product and/or...
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Regulatory Affairs Specialist
3 months ago
Santa Clara, United States GForce Life Sciences Full timeRegulatory Affairs Specialist– Santa Clara, CA Must be able to work on a W2 Job Summary: We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and commercial, and affiliate personnel in the medical device industry.Key...
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Regulatory Affairs Specialist
3 months ago
Santa Clara, United States GForce Life Sciences Full timeRegulatory Affairs Specialist– Santa Clara, CA Must be able to work on a W2 Job Summary: We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and commercial, and affiliate personnel in the medical device industry.Key...
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Head of CMC Regulatory Affairs
6 hours ago
Santa Clara, California, United States Bayside Solutions Full timeDirector, CMC Regulatory Affairs - Strategic Leadership Opportunity at Bayside Solutions, Inc.Full-Time Position with Direct HireCompensation: Competitive salaryLocation: Flexible Hybrid Work EnvironmentPosition Overview:In the role of Director of CMC Regulatory Affairs, you will be instrumental in shaping and executing regulatory frameworks that facilitate...
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Head of CMC Regulatory Affairs
6 days ago
Santa Clara, California, United States Bayside Solutions Full timeChief, CMC Regulatory Affairs - Strategic Leadership Opportunity at Bayside Solutions, Inc.Position Type: Full-Time with Direct HireCompensation: Competitive salary offeredLocation: Hybrid Work Environment in Redwood City, CAPosition Overview:In the role of Chief of CMC Regulatory Affairs, you will be instrumental in formulating and executing regulatory...
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Head of CMC Regulatory Affairs
15 hours ago
Santa Clara, California, United States Bayside Solutions Full timeChief of CMC Regulatory Affairs - Pivotal Opportunity at Bayside Solutions, Inc.Position Type: Full-Time with Direct HireCompensation: Competitive salary packageLocation: Dynamic Redwood City, CA - Hybrid Work SettingRole Overview:In the capacity of Chief of CMC Regulatory Affairs, you will be instrumental in crafting and executing regulatory frameworks that...
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Head of CMC Regulatory Affairs
15 hours ago
Santa Clara, California, United States Bayside Solutions Full timeChief, CMC Regulatory Affairs - Pivotal Opportunity at Bayside Solutions, Inc.Full-Time Employment with Direct HireCompensation: Competitive salaryLocation: Dynamic Redwood City, CA - Hybrid Work EnvironmentPosition Overview:In the role of Chief of CMC Regulatory Affairs, you will be instrumental in formulating and executing regulatory strategies that...
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Head of CMC Regulatory Affairs
6 hours ago
Santa Clara, California, United States Bayside Solutions Full timeDirector, CMC Regulatory Affairs - Key Leadership Position at Bayside Solutions, Inc.Full-Time Role with Direct Hire OpportunityCompensation: Competitive salary packageLocation: Dynamic Redwood City, CA - Hybrid Work ModelPosition Overview:In the role of Director of CMC Regulatory Affairs, you will be instrumental in shaping and executing regulatory...
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Head of CMC Regulatory Affairs
6 hours ago
Santa Clara, California, United States Bayside Solutions Full timeDirector, CMC Regulatory Affairs - Strategic Leadership Opportunity at Bayside Solutions, Inc.Full-Time Role with Direct HireCompensation: Competitive salary packageLocation: Dynamic Redwood City, CA - Hybrid Work SettingPosition Overview:In the role of Director of CMC Regulatory Affairs, you will be instrumental in shaping and executing regulatory...
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Santa Clara, California, United States Intellectt Inc Full timePosition: Senior Quality/Regulatory Affairs SpecialistCompany: Intellectt IncRole Overview:As a Senior Quality/Regulatory Affairs Specialist, you will play a pivotal role in ensuring compliance and quality within the regulatory affairs sector. Your expertise will be essential in supporting the regulatory affairs team from a quality assurance and compliance...
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Regulatory Affairs, CMC Consultant
3 weeks ago
Santa Clara, United States Bayside Solutions Full timeRegulatory Affairs, CMC ConsultantW2 ContractLocation: Redwood City, CA - Hybrid or Remote PSTJob Summary:In this role, you will be responsible for providing CMC regulatory strategies and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual marketing approval of our pipeline compounds and...
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Regulatory Affairs, CMC Consultant
3 weeks ago
Santa Clara, United States Bayside Solutions Full timeRegulatory Affairs, CMC ConsultantW2 ContractLocation: Redwood City, CA - Hybrid or Remote PSTJob Summary:In this role, you will be responsible for providing CMC regulatory strategies and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual marketing approval of our pipeline compounds and...
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Regulatory Affairs, CMC Consultant
3 weeks ago
Santa Clara, United States Bayside Solutions Full timeRegulatory Affairs, CMC ConsultantW2 ContractLocation: Redwood City, CA - Hybrid or Remote PSTJob Summary:In this role, you will be responsible for providing CMC regulatory strategies and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual marketing approval of our pipeline compounds and...
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Regulatory Affairs, CMC Consultant
3 weeks ago
Santa Clara, United States Bayside Solutions Full timeRegulatory Affairs, CMC ConsultantW2 ContractLocation: Redwood City, CA - Hybrid or Remote PSTJob Summary:In this role, you will be responsible for providing CMC regulatory strategies and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual marketing approval of our pipeline compounds and...
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Regulatory Affairs, CMC Consultant
1 day ago
santa clara, United States Bayside Solutions Full timeRegulatory Affairs, CMC ConsultantW2 ContractLocation: Redwood City, CA - Hybrid or Remote PSTJob Summary:In this role, you will be responsible for providing CMC regulatory strategies and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual marketing approval of our pipeline compounds and...
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Senior Regulatory Affairs Consultant
5 days ago
Santa Clara, California, United States Direct Staffing Inc Full timePosition Overview:We are seeking a highly skilled regulatory professional to join our Companion Diagnostics (CDx) team. The successful candidate will report to the Sr. Director of Regulatory Affairs (CDx) and must possess extensive global regulatory experience in In Vitro Diagnostics (IVD), Medical Devices, or Pharmaceuticals, with a proven track record of...
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Senior Regulatory Affairs Consultant
5 days ago
Santa Clara, California, United States Direct Staffing Inc Full timePosition Overview:We are seeking a highly skilled regulatory professional to join our Companion Diagnostics (CDx) team. The successful candidate will report directly to the Sr. Director of Regulatory Affairs (CDx) and must possess extensive global regulatory experience in In Vitro Diagnostics (IVD), Medical Devices, or Pharmaceuticals. A proven track record...
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Regulatory Affairs Project Manager
2 months ago
Job Title: Regulatory Affairs Project Manager
Location: Santa Clara, CA-95054 (100% Onsite)
Duration: 12 months contract
Shift: 8am-5pm
Job Roles & Responsibilities:
Support IVDR compliance activities including creation of technical files, post market surveillance activities
New product development documentation
On market support:
Regulatory impact assessments, etc.
Regulatory operations:
BUDI number updates, label reviews, FDA laser report, state manufacturing license etc.
Product Develop
Regulatory Support
Impact Regulatory Support
Supporting Application for state license in US
5 years' experience
Organized Skillset
Be aware of regulations, Medical Device
IVDR for US and Europe
Exp working in an ISO Certified environment. ISO 13485
Experience working in regulatory environment
Preferred
5 years Exp. Invitro Diagnostic Medical Devices