Current jobs related to Regulatory Affairs Specialist - Santa Clara - SPECTRAFORCE
-
Regulatory Affairs Specialist
7 days ago
Santa Clara, California, United States Shockwave Medical Full timeJob Title: Principal Regulatory Affairs SpecialistShockwave Medical, Inc. is a pioneering company in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease.We are seeking a highly skilled Principal Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs...
-
Regulatory Affairs Specialist
2 weeks 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 Specialist
2 weeks 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...
-
Lead Quality and Regulatory Affairs Specialist
1 month 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
1 week 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...
-
Senior Regulatory Affairs Specialist
4 days ago
Santa Clara, California, United States Shockwave Medical Full timeJob Title: Senior Regulatory Affairs SpecialistShockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our mission is to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through our differentiated...
-
Regulatory Affairs Specialist
1 week ago
Santa Clara, California, United States Shockwave Medical Full timeJob Title: Regulatory Operations SpecialistShockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease.We are seeking a highly skilled Regulatory Operations Specialist to join our team. As a key member of our Regulatory Affairs department, you will play a...
-
Senior Regulatory Affairs Specialist
2 weeks ago
Santa Clara, California, United States Abbott Laboratories Full timeAbout the RoleAbbott Laboratories is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team in Santa Clara, CA. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the efficient and compliant business processes and environment.Key ResponsibilitiesProvide regulatory input to product lifecycle...
-
Regulatory Affairs Senior Specialist
1 month ago
Santa Clara, California, United States Abbott Full timeAbout Abbott:Abbott is a prominent global healthcare organization dedicated to enhancing the quality of life for individuals at every stage of their journey. Our extensive range of transformative technologies encompasses various healthcare sectors, including diagnostics, medical devices, nutritionals, and branded generic medications. With a workforce of...
-
Senior Regulatory Affairs Specialist
3 weeks 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...
-
Regulatory Affairs Specialist II
2 weeks 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...
-
Regulatory Affairs Specialist
4 days ago
Rancho Santa Margarita, California, United States Applied Medical Full timePremarket Regulatory Affairs SpecialistApplied Medical is a leading medical device company with a strong commitment to innovation and excellence. We are seeking a highly skilled Premarket Regulatory Affairs Specialist to join our team.The successful candidate will play a critical role in ensuring compliance with regulatory requirements during the early...
-
Lead Specialist in Regulatory Affairs
1 month ago
Santa Clara, California, United States Abbott Full timeLead Specialist in Regulatory AffairsAbbott stands as a prominent figure in the global healthcare sector, dedicated to enhancing the quality of life for individuals at every stage. Our extensive range of transformative technologies encompasses various healthcare domains, featuring top-tier businesses and products in diagnostics, medical devices,...
-
Regulatory Affairs Specialist
7 days ago
Santa Clarita, California, United States huMannity Medtec Full timePrincipal Regulatory Affairs SpecialistAt huMannity Medtec, we are committed to developing life-enhancing medical technologies that address unmet healthcare needs. Our team of engineers, scientists, and medical device experts is dedicated to creating innovative solutions for the challenges of tomorrow.We are seeking an experienced and highly motivated...
-
Regulatory Affairs Specialist
2 months 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...
-
Regulatory Affairs Specialist
1 week ago
Rancho Santa Margarita, California, United States Applied Medical Full timePremarket Regulatory Affairs SpecialistAt Applied Medical, we are seeking a highly skilled Premarket 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 regulatory requirements during the early stages of product development.Key Responsibilities:Coordinate and manage...
-
CMC Regulatory Affairs Director
2 days ago
Santa Clara, California, United States Bayside Solutions Full timeJob Title: Director, CMC Regulatory AffairsAt Bayside Solutions, we are seeking a highly experienced Director, CMC Regulatory Affairs to join our team. As a key member of our regulatory affairs department, you will be responsible for providing strategic guidance on CMC regulatory strategies and leading the preparation of CMC sections of regulatory...
-
Head of CMC Regulatory Affairs
4 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...
-
Head of CMC Regulatory Affairs
1 month 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
4 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...
Regulatory Affairs Specialist
3 months ago
Title: Regulatory Affairs Project Leader
Duration: 12 Months
Location: Santa Clara, CA 95054
Description:
Education: Bachelor's degree required, Masters degree preferred
Experience: Minimum of 3 years experience
Skills: Knowledge of US and/or Canadian regulation relating to product and/or device clearance (FDA)
Duties:
- 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.