Regulatory Affairs Specialist II
4 weeks ago
We are seeking a highly skilled Regulatory Affairs Specialist II to join our team at Boston Scientific. As a key member of our regulatory team, you will play a critical role in supporting the preparation of submissions to obtain various worldwide approvals for commercially distributing products.
Key Responsibilities- Support the preparation of submissions (e.g., PMA, PMA supplements, CE marking applications) to obtain various worldwide approvals to commercially distribute products
- In conjunction with Clinical Research, support the preparation of applications (e.g., IDE, IDE supplements, Investigator Brochure) for conducting clinical investigations in U.S., Canada, Australia, and EU countries
- Prepare required submissions (progress reports, etc.) to facilitate the continuation of clinical studies
- Participate in the review and submission activities (annual reports, change notifications, etc.) to support the maintenance of marketing approvals
- Support product registrations for international markets as required
- Participate in project development teams and review plans, reports, risk management, and design reviews associated with product and process projects
- A minimum of a bachelor's degree and 1-3 years' work experience in regulatory affairs
- Prior experience with class III Medical Devices
- Knowledge and experience with U.S. FDA, Canada, EU, and/or international regulations and standards
- Effective written and oral communication, technical writing, and editing skills
- Interpersonal, communication, and negotiating skills
- Works well in fast-paced cross-functional team environments
- RA certification (by Regulatory Affairs Professional Society)
This is a hybrid position (in office minimum three days per week) with a preferred location in Valencia, CA, with flexibility to be located in other US BSC locations. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.
Boston Scientific is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive workplace that reflects the diversity of our patients, customers, and communities.
-
Regulatory Affairs Specialist
4 weeks ago
Santa Clarita, California, United States CC Wellness Full timeAbout CC WellnessCC Wellness is a rapidly growing pharmaceutical company dedicated to delivering innovative personal care and intimate wellness products with a focus on social responsibility and science-based innovation.Our mission is to make a positive impact on people's lives by providing high-quality products that meet the highest standards of safety and...
-
Regulatory Affairs Expert
4 weeks ago
Santa Clarita, California, United States huMannity Medtec Full timeAbout the RoleAt huMannity Medtec, we are pioneers in life-enhancing medical technologies for underserved healthcare needs. We are seeking a highly motivated and experienced Principal Regulatory Affairs Specialist to join our team of engineers, scientists, and medical device experts.This is an excellent opportunity to make a difference in people's lives by...
-
Regulatory Affairs Specialist
4 weeks 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...
-
Regulatory Affairs Specialist
3 weeks ago
Santa Clara, California, United States Shockwave Medical Full timeJob SummaryThe Principal Regulatory Affairs Specialist at Shockwave Medical is a key member of our team, responsible for ensuring that our medical devices meet regulatory requirements. This role requires a strong understanding of scientific, regulatory, and business issues, as well as excellent communication and project management skills.Key...
-
Santa Clara, California, United States Abbott Laboratories Full timeAbout AbbottAbbott is a global healthcare leader that drives innovation to improve people's lives. With a diverse portfolio of life-changing technologies, we're committed to advancing the future of healthcare.Job SummaryWe're seeking a Senior Regulatory Affairs Specialist to join our team in Santa Clara, CA. As a key member of our regulatory department,...
-
Regulatory Affairs Senior Manager
2 weeks ago
Santa Rosa, California, United States Medtronic Full timeRegulatory Affairs Senior Manager Job DescriptionMedtronic Structural Heart seeks an experienced Regulatory Affairs Senior Manager to develop and execute global regulatory strategies for innovative transcatheter valve technologies. This role will report to the Vice President of Regulatory Affairs and oversee a team of professionals.Key...
-
Regulatory Affairs Manager
4 weeks ago
Santa Monica, California, United States Neogene Therapeutics Full timeJob Title: Manager, Regulatory AffairsAt Neogene Therapeutics, we are committed to harnessing the power of science to drive innovation and make a meaningful impact on patients' lives. As a Manager, Regulatory Affairs, you will play a critical role in supporting the development and successful performance of our CMC regulatory strategy for our innovative...
-
Regulatory Affairs Project Manager
4 weeks ago
Santa Clara, California, United States Collabera Full timeJob Summary:Collabera is seeking a highly skilled Regulatory Affairs Project Leader to join our team. As a key member of our regulatory team, you will be responsible for managing and tracking broad and strategic projects, communicating effectively in writing crisp briefings and issue analysis, and demonstrating ability to work effectively in a team...
-
Regulatory Affairs Project Manager
3 weeks ago
Santa Clara, California, United States Collabera Full timeJob DescriptionWe are seeking a highly skilled Regulatory Affairs Project Leader to join our team at Collabera. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for medical devices.Key Responsibilities:Assist in the development and implementation of regulatory strategies and...
-
Senior Manager, Regulatory Affairs Lead
4 weeks ago
Santa Rosa, California, United States Medtronic Full timeJob Title: Senior Manager, Regulatory AffairsMedtronic is seeking an experienced Senior Manager of Regulatory Affairs to play a crucial role in the development and execution of global regulatory strategies for innovative transcatheter valve technologies.About the Role:This individual will oversee a team of professionals and contribute to the development of...
-
Regulatory Affairs Project Leader
4 weeks ago
Santa Clara, California, United States Collabera Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Project Leader to join our team at Collabera. The successful candidate will be responsible for leading regulatory projects and ensuring compliance with US and international regulations.Key Responsibilities:Develop and implement regulatory strategies and priorities in conjunction with management...
-
Regulatory Affairs Project Manager
4 weeks ago
Santa Clara, California, United States Collabera Full timeJob OverviewCollabera is seeking a highly skilled Regulatory Affairs Project Leader to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to achieve business objectives.Key ResponsibilitiesDevelop and implement regulatory strategies to support business...
-
Public Affairs Mass Communication Specialist
4 weeks ago
Santa Barbara, California, United States U.S. Army Full timeJob Title: Public Affairs Mass Communication SpecialistAs a Public Affairs Mass Communication Specialist in the U.S. Army, you will play a crucial role in supervising and assisting the administration of Army public affairs programs. Your responsibilities will include researching, preparing, and distributing news releases, articles, web-based material, and...
-
Regulatory Compliance Manager II
4 weeks ago
Santa Barbara, California, United States County of Santa Barbara, CA Full timeJob Title: Regulatory Compliance Manager IIJoin the County of Santa Barbara, CA, as a Regulatory Compliance Manager II and play a vital role in ensuring the county's public works infrastructure, facilities, and services meet the highest standards of environmental health and safety.Key Responsibilities:Oversee staff performing work in a highly regulated...
-
Regulatory Compliance Manager II
4 weeks ago
Santa Barbara, California, United States County of Santa Barbara, CA Full timeJob SummaryWe are seeking a highly skilled Regulatory Compliance Manager II to join our team at the County of Santa Barbara, CA. As a key member of our Public Works Department, you will be responsible for overseeing staff performing work in a highly regulated environment, including establishing regulations, monitoring compliance, and taking enforcement and...
-
Regulatory Compliance Specialist
4 weeks ago
Santa Monica, California, United States Cedars-Sinai Full time**Job Summary:**As a Regulatory Compliance Specialist at Cedars-Sinai, you will play a critical role in ensuring the integrity of our research studies and clinical trials. Your primary responsibility will be to prepare and submit protocols and supporting documentation to regulatory bodies and research committees, ensuring compliance with federal and local...
-
Clinical Research Specialist
3 weeks ago
Santa Monica, California, United States LanceSoft Full timeJob Title:Clinical Trial Education and Literature Review SpecialistJob Summary:We are seeking a detail-oriented and analytical Clinical Trial Education and Literature Review Specialist to support the development and submission of clinical trial education materials to the Promotional Review Committee (PRC).This role is responsible for conducting comprehensive...
-
Regulatory Compliance Manager II
3 weeks ago
Santa Barbara, California, United States County of Santa Barbara, CA Full timeJob SummaryThe County of Santa Barbara, CA is seeking a highly qualified Regulatory Compliance Manager II to join our team. This is a full-time position that requires a strong background in environmental health and safety compliance, as well as experience in managing regulatory programs and projects.Key ResponsibilitiesOversee staff performing work in a...
-
Regulatory Compliance Manager II Position
3 weeks ago
Santa Barbara, California, United States County of Santa Barbara Full timeJob SummaryThe County of Santa Barbara is seeking a highly skilled Regulatory Compliance Manager II to join our team. This is a challenging and rewarding opportunity for a motivated individual to make a meaningful contribution to our organization.Key ResponsibilitiesOversee staff performing work in a highly regulated environment, including establishing...
-
Regulatory Compliance Manager II
4 weeks ago
Santa Barbara, California, United States County of Santa Barbara Full timeJob Summary:The County of Santa Barbara is seeking a highly skilled Regulatory Compliance Manager II to oversee staff performing work in a highly regulated environment. The ideal candidate will have experience in air quality, engineering, and/or solid waste, and will be able to establish regulations, monitor compliance, and take enforcement and corrective...