Senior Manager Regulatory Affairs Specialist

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...

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 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...

Position Overview:Reporting directly to the Senior Vice President of Regulatory Affairs, the Senior Manager or Associate Director of Regulatory Affairs will spearhead and engage in regulatory initiatives related to IND/CTA preparations and ongoing maintenance to facilitate both new and existing development programs. This position demands a proactive,...

Position Overview:Reporting to the Senior Vice President of Regulatory Affairs, the Regulatory Affairs Senior Manager or Associate Director will spearhead and engage in regulatory initiatives related to IND/CTA preparation and ongoing maintenance to facilitate both new and existing development programs. This position necessitates a proactive,...

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...

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...

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...

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...

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...

Senior Regulatory Affairs SpecialistGenalyte, Inc., a frontrunner in cutting-edge diagnostic solutions, is seeking a highly qualified and driven Senior Regulatory Affairs Specialist to become part of their innovative team. In this position, you will be tasked with navigating intricate regulatory frameworks to guarantee adherence to all standards and...

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...

About Danaher Corporation: Danaher Corporation is a global leader in the life sciences and diagnostics sectors, committed to innovation and excellence in our products and services.Position Overview: We are seeking a Senior Specialist in Regulatory Affairs for Core and NGS Technologies. This role is integral to our Quality Assurance and Regulatory Affairs...

Job Title: Regulatory Specialist, R&DJob Summary:We are seeking a highly skilled Regulatory Specialist to join our R&D team. As a key member of our team, you will be responsible for implementing worldwide regulatory programs for developing and marketed products, interacting with regulatory authorities to expedite approvals, and providing regulatory expertise...

Position Title: Regulatory Affairs SpecialistCompany: Katalyst HealthCares & Life SciencesEmployment Type: ContractDuration: 12 monthsDepartment: Regulatory AffairsQualifications: Bachelor’s or Master’s degree in a relevant Scientific Discipline At least 7 years of experience in the pharmaceutical sector Minimum of 5 years of experience in CMC regulatory...

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...

Regulatory Affairs Specialist Opportunity at CorDxCorDx, a prominent biotechnology firm committed to advancing global health, is seeking a Regulatory Affairs Specialist to enhance our proactive Regulatory Affairs division. In this pivotal role, you will be instrumental in ensuring adherence to FDA standards for our In Vitro Diagnostics (IVD) offerings.Key...

About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist II to join our team at Tandem Diabetes Care. As a key member of our regulatory team, you will be responsible for ensuring medical device compliance with all global applicable regulations for regulatory projects to meet corporate objectives.Key ResponsibilitiesSupports Regulatory...

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...