Senior Regulatory Affairs Specialist

R&D Partners is looking for a Senior Regulatory Affairs Specialist III. Key Responsibilities: Support for marketed products, including reviewing engineering modifications, labeling, promotional content, product alterations, and documentation to ensure compliance with both US and international regulatory standards.Draft and maintain submissions and product...

Senior Regulatory Affairs SpecialistWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at ACON Laboratories. As a key member of our regulatory affairs team, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.Key Responsibilities:Coordinate the preparation and...

Job SummaryRegulatory Affairs Specialist - CMCThis position manages multiple biological developmental projects with supervision, including working with contract manufacturing organizations CMO. The successful candidate will serve as the Regulatory Affairs (RA) CMC project representative to the CMC sub-team and the RA team, and will serve as an ad hoc member...

Senior Regulatory Affairs SpecialistWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at BioTalent. This is a hybrid on-site role that requires at least 5-7+ years of hands-on Regulatory experience, including 510(k) authorship.Key Responsibilities:Document Coordination: Coordinate submission and review of documents for...

Senior Regulatory Affairs Specialist **About the Role** We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at ACON Laboratories. As a key member of our regulatory affairs team, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements. **Key Responsibilities** *...

Senior Staff Regulatory Affairs SpecialistWe are seeking a highly skilled Senior Staff Regulatory Affairs Specialist to join our Endoscopy division based in San Jose, CA. This is a hybrid role that requires on-site presence three days a week.Key ResponsibilitiesSupport business development activities and participate in the integration of Regulatory roles and...

Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at San Francisco Health Plan. As a key member of our Compliance and Regulatory Affairs Department, you will play a critical role in ensuring our organization's compliance with state and federal regulations.Key ResponsibilitiesSubmit regulatory reports, including the...

About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Pharmatech Associates. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the compliance of our clients' projects with global regulatory requirements.Key ResponsibilitiesCMC and Clinical Regulatory Expertise: You will...

Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at San Francisco Health Plan. As a key member of our Compliance and Regulatory Affairs Department, you will play a critical role in ensuring compliance with state and federal regulations, as well as developing and implementing policies to support our mission.Key...

Job Title: Director/Senior Director RegulatoryAbout Abdera TherapeuticsAbdera Therapeutics is a precision oncology company developing next-generation targeted radiation therapies. We are a rapidly growing company seeking key new team members who thrive at the cutting-edge of innovation.Job SummaryWe are looking for a highly experienced and skilled...

Job Title: Director/Senior Director RegulatoryAbout Abdera TherapeuticsAbdera Therapeutics is a precision oncology company developing next-generation targeted radiation therapies. We are a rapidly growing company seeking key new team members who thrive at the cutting-edge of innovation.Job SummaryWe are looking for a highly experienced and skilled...

Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Compliance and Regulatory Affairs Department, you will play a critical role in ensuring our organization's compliance with state and federal regulations.Key ResponsibilitiesSubmit regulatory reports, including the annual Timely Access Report, to...

Senior Regulatory Affairs SpecialistAt ACON Laboratories, we are committed to delivering innovative medical devices that enhance human life. We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team.The successful candidate will be responsible for coordinating the accumulation of technical information and preparing submissions for...

R&D Partners is in search of a Senior Regulatory Affairs Consultant. Key Responsibilities: Support ongoing marketed products by reviewing engineering modifications, promotional materials, labeling, and documentation to ensure compliance with both US and international regulatory standards.Draft and maintain product technical files while overseeing compliance...

Job SummaryAnnexon Biosciences is seeking an experienced Executive Director/Senior Director, Regulatory Affairs to provide global regulatory leadership and direction to support the development, registration, and life-cycle management of innovative programs within the Annexon portfolio.Key ResponsibilitiesDevelop and implement regulatory strategies and plans...

About the Role:We are seeking a highly skilled Compliance and Regulatory Affairs Analyst to join our Compliance department at Upgrade, Inc.In this role, you will partner closely with internal stakeholders to prepare regulatory examinations and track changes to regulations to ensure ongoing compliance.We are looking for someone with a can-do attitude, a keen...

About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Tandem Diabetes Care. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our medical devices.Key ResponsibilitiesPrepare and maintain domestic and international regulatory filings...

Position OverviewInternational Regulatory Specialist (EU MDR) - Medical DeviceRole Summary:The International Regulatory Specialist is primarily accountable for ensuring adherence to EU regulatory standards and oversees the international regulatory submission framework.Essential Qualifications:Required Qualifications:Education: Bachelor's degree in a relevant...

Position OverviewInternational Regulatory Specialist (EU MDR) - Medical DeviceRole Summary:The International Regulatory Specialist is tasked with ensuring adherence to EU regulatory standards and oversees the comprehensive international regulatory submission process.Essential Qualifications:Required - Minimum Qualifications:Education: Bachelor's...

Job OverviewInternational Regulatory Specialist (EU MDR) - Medical DevicePosition SummaryThe International Regulatory Specialist is tasked with ensuring adherence to EU regulatory standards and is responsible for overseeing the international regulatory submission framework.Essential Qualifications:Required - Minimum Qualifications:Education: Bachelor's...