Current jobs related to Regulatory Affairs Project Leader - Santa Clara - Collabera
-
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...
-
Regulatory Affairs Project Manager
3 weeks ago
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...
-
Regulatory Affairs Specialist
3 days ago
Santa Clara, California, United States Abbott Laboratories company Full timeAbout Abbott LaboratoriesAbbott Laboratories 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 MissionOur business purpose is...
-
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...
-
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...
-
Regulatory Affairs Specialist
3 days ago
Santa Clara, California, United States Abbott Laboratories Full timeAbout Abbott LaboratoriesAbbott Laboratories 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.We're always looking towards the...
-
Regulatory Affairs Specialist
4 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...
-
Regulatory Affairs Specialist
4 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...
-
Head of CMC Regulatory Affairs
3 weeks 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...
-
Head of CMC Regulatory Affairs
3 weeks 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...
-
Head of CMC Regulatory Affairs
3 weeks 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...
-
Head of CMC Regulatory Affairs
3 weeks 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...
-
Head of CMC Regulatory Affairs
3 weeks 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...
-
Regulatory Affairs Director
2 weeks ago
Santa Clara, California, United States Bayside Solutions Full timeJob Summary:The position is responsible for providing strategic guidance on CMC regulatory matters and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual marketing approval of pipeline compounds/products.Key Responsibilities:Develop and implement CMC regulatory strategies to support the clinical...
-
Head of CMC Regulatory Affairs
3 weeks 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...
-
Regulatory Affairs Specialist II
3 days ago
Santa Clara, California, United States Abbott Laboratories company Full timeAbout Abbott LaboratoriesAbbott Laboratories 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 MissionOur business purpose is to...
-
Senior Regulatory Affairs Specialist
1 week ago
Santa Clara, California, United States Abbott Laboratories Full timeAbout the RoleAbbott Laboratories, a global healthcare leader, is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory department, you will play a critical role in ensuring efficient and compliant business processes and environment.Key ResponsibilitiesStrategic Planning:Provide regulatory input to...
-
Lead Quality and Regulatory Affairs Specialist
3 weeks ago
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...
-
Regulatory Affairs Expert
2 days ago
Santa Clara, California, United States VirtualVocations Full timeVirtualVocations is seeking a seasoned Regulatory Affairs Specialist to lead our medical device product submissions. Key Responsibilities: * Provide strategic regulatory guidance for medical device products, including AI/ML-enabled devices * Lead cross-functional teams on regulatory decision-making and guide regulatory submission teams * Conduct regulatory...
-
CMC Regulatory Affairs Director
1 week ago
Santa Clara, California, United States Bayside Solutions Full timeJob Summary:The position is responsible for providing strategic guidance on CMC regulatory matters and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual marketing approval of pipeline compounds/products.Key Responsibilities:Develop and implement CMC regulatory strategies to support the clinical...
Regulatory Affairs Project Leader
4 months ago
Job Description
Job 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 device submissions.
·
Hands-on experience with 510k submission, or PMA/s or US Annual report or CE Technical Documentation preparation.
·
Assists in
definition/implementation
of regulatory strategy and priorities in conjunction with management, peers, commercial, and affiliate personnel.
·
Communicates issues to management through project management tracking and issue briefings.
·
Position is highly visible to internal and external stakeholders.
·
High level of effective verbal and written communication skills must be demonstrated, including ability to negotiate, influence, and manage conflict. Prior regulatory experience in the medical device, food, dietary supplement, or pharmaceutical industry is strongly preferred, but not required.
·
Ability to work constructively, decisively, and collegiality with internal customers (scientists, marketing, quality assurance, product development, affiliates) to solve problems and communicate regulatory needs.
·
Ability to manage and track broad and strategic projects.
·
Ability to communicate effectively in writing crisp briefings and issue analysis.
·
Demonstrated ability to work effectively in a team environment.
·
Responsible for tracking and timely completion of regulatory strategies and issues, scientific substantiation for product claims, and label material activities.
·
Responsible for effective communication of regulatory requirements to project teams and internal customers.
Additional Notes:
·
Must have RA submission experience. and EU & MU submissions experience
·
good writing and communication skills - Word, Excel
·
Bachelor's degree in engineering or science and a minimum of 3 years of experience of regulatory affairs
Day to day:
·
Registrations - will train to do this up to 200 pages of documentation formatting
·
Complete technical documents for different Countries and submit to government agencies as well as the US.
Company Description Collabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.
Company Description
Collabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.
#J-18808-Ljbffr