We have other current jobs related to this field that you can find below
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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 Project Manager
6 days 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...
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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 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 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 - 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 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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Regulatory Affairs Specialist
1 month ago
Santa Clara, 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.About...
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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...
![The Fountain Group](https://media.trabajo.org/img/noimg.jpg)
Regulatory Affairs Project Leader
2 months ago
Hello,
My name is Shivaraj, and I am a Scientific Talent Acquisition Consultant with The Fountain Group. We are a national staffing firm with an array of Fortune 500 clients constantly looking for candidates such as yourself to join the team.
Currently I have an opening for a Regulatory Affairs Specialist at Santa Clara, CA Details for the position are as follows:
Pay: $59-55
Location: Santa Clara, CA, Need to onsite (Open to relocation)
Contract duration: 1 Year + Extension/Perm
Job Description:
Qualificaion:
Bachelor's degree required, Masters degree preferred with minimum 3 years experience
Must need Skills:
- Knowledge of US and/or Canadian, EU regulation relating to product and/or device clearance (FDA)
- Creation and/or maintenance of EU MDR Technical Documentation
- Prepare and submit product for international registration
- PMA, IDE submission
- 510(k) submission
- 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/promotional material activities.
- Responsible for effective communication of regulatory requirements to project teams and internal customers..