Senior Regulatory Affairs Lead - IVD/Med Devices (Remote)
Biocartis
- Remote job
Biocartis is searching for a Senior Regulatory Affairs Specialist to develop regulatory strategies for compliance with IVDR and global standards. This remote position requires a Bachelor's degree and at least 5 years of experience in Regulatory Affairs, preferably with IVD or software. Key responsibilities include collaborating with cross-functional teams, preparing regulatory submissions, and monitoring changing market requirements. The successful candidate will be part of a dynamic team in an innovative biotech environment, with a competitive compensation package. #J-18808-Ljbffr Biocartis
$103k - $130k
...a Sr. Clinical Research Associate to manage IVD and medical device clinical trials from start to finish. This fully remote role involves oversight of study protocol execution... ...experience, with the ability to navigate regulatory requirements. Competitive salary range of $10...Remote jobSenior$115k - $185k
...A medical device company is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions and strategy for new product development. This role offers flexibility in levels and can be remote, aligned with US East Coast hours. Candidates should have a Bachelor...Remote workSenior$92.7k - $152.9k
Dart Solutions is seeking a Senior International Regulatory Affairs Specialist based in Milpitas, CA. This role supports the global commercialization of diagnostic devices by managing regulatory submissions. Candidates should have a Bachelor’s degree and significant experience...Senior- A healthcare technology company is seeking a Sr. Regulatory Affairs Specialist in Somerville, Massachusetts, to support the commercialization... ...environment, and strong communication skills. This position is remote and requires some travel. Competitive salary and benefits...Remote jobSenior
$110k - $135k
Integrated DNA Technologies is looking for a Regulatory Affairs Specialist to manage regulatory... ...life sciences and diagnostics. You will lead the creation of regulatory documents and... ...vitro diagnostics. This position is fully remote, offers a salary range of $110,000 - $1...Remote jobSenior$212k - $333.19k
...therapies to patients worldwide. About the Role As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations Human Factors, you... ...classified as "hybrid" following Takeda's Hybrid and Remote Work policy. Compensation and Benefits Summary...Remote workSeniorMinimum wageFull timeTemporary workLocal areaWorldwideNight shift- DNV Germany Holding GmbH is seeking a Senior Lead Auditor - Medical Devices for our office in Houston, TX. The role involves implementing ISO13485 and... ...reporting skills. This hybrid position allows for periodic remote work, with 85% domestic travel expected. Successful...Remote workSeniorWork at office
$106k - $197k
F. Hoffmann-La Roche AG is looking for a Regulatory Affairs expert in Indianapolis to oversee regulatory documentation and submissions... ..., along with several years of relevant experience in IVDs/medical devices. A salary range of $106,000-$197,000 is anticipated, and...- ...Seattle is seeking applicants for the Senior Cardiac Device Technician position. This role involves... ...cardiac devices and managing remote transmissions. The ideal candidate should... ...comprehensive health care packages. Join a leading not-for-profit healthcare system committed...Remote workSeniorFull timePart time
- Armiusa seeks a Senior Regulatory Affairs Consultant to develop regulatory strategies and ensure compliance for complex biologics and devices. Candidates should have extensive experience in regulatory affairs and a strong educational background in life sciences or engineering...Senior
- Enovis Corp is seeking a Senior Regulatory Affairs Specialist in Austin, TX to develop and execute regulatory strategies for medical devices. This role is essential for managing product submissions and ensuring compliance with FDA, EU, and TGA regulations. The ideal candidate...Senior
- BioRobotics is looking for a Principal Regulatory Affairs Specialist to provide regulatory leadership from product development through marketing... .... The role requires a minimum of 12 years in the medical device industry, with strong knowledge of regulatory standards and excellent...Senior
- AbbVie is seeking a Senior Manager, Regulatory Affairs in California to work closely with internal and external partners, preparing regulatory strategies and submissions for devices. The ideal candidate will leverage eight years of pharmaceutical experience, particularly...Senior
- Katalyst HealthCares and Life Sciences in North Chicago is seeking a Regulatory Affairs Level III (Senior Specialist) focused on global product registrations and regulatory compliance for medical devices. Candidates should have 5-7 years of experience in regulatory...Senior
- BioRobotics is seeking a Senior Regulatory Affairs Specialist at their California headquarters to oversee... ...surgery innovations. You'll lead cross-functional teams, develop regulatory... ...driving continuous improvement for medical devices. Join us to make a meaningful...Senior
$89.2k - $169.5k
Boston Scientific Gruppe is looking for a Senior Regulatory Affairs Specialist in Marlborough, MA. The role involves regulatory support for new submissions and compliance in the medical device industry. Candidates must have at least 4 years of relevant experience, including...Senior- Quest Medical Inc. is looking for a Senior Regulatory Specialist in Allen, Texas. The ideal candidate... ...and substantial experience in medical device regulatory affairs, particularly with Class II/III devices. This role includes leading submissions and preparing regulatory...Senior
- A leading regulatory consultancy located in New Jersey is seeking an experienced Regulatory Affairs specialist. The role involves supporting US and EU regulatory submissions while... ...adherence to regulations concerning medical devices. The ideal candidate should have over 7...SeniorWork at office
- C20 Cochlear Americas (USA) is seeking a Senior Regulatory Affairs Specialist to provide regulatory support and guidance in a hybrid work environment... ...compliance with regulatory requirements for all medical devices, contributing to Cochlear’s business objectives. The ideal...Senior
- Downtown Boulder Partnership is seeking a Senior Regulatory Affairs Specialist in Lawrence, MA. The role involves implementing regulatory strategies... ...and 6-8 years of regulatory experience in the medical device industry. The position requires strong communication skills...Senior
- West Pharmaceutical Services, Inc is hiring a Principal Regulatory Affairs Project Manager based in Exton, PA. This hybrid role calls for a leader to oversee regulatory programs for medical devices, focusing on strategy, compliance, and project management. The successful...Senior
- ...A biopharmaceutical company is seeking a Senior Manager, Global Regulatory Affairs Labeling to lead its global labeling initiatives. This role involves strategy... ...regulations. The position offers a competitive salary and the flexibility of remote work. #J-18808-Ljbffr...Remote workSenior
- Abbott Laboratories in Alameda, CA is seeking a Senior Regulatory Affairs Specialist to support product development and regulatory activities. This... ..., and ensuring compliance for Class II software medical devices. Candidates should have a bachelor's degree in a technical...Senior
$110k - $155k
Tempus AI, Inc. is seeking a Lead Quality Engineer to join its multidisciplinary team in Chicago. This role... ...quality assurance for the development of IVD medical devices and LDT products while overseeing regulatory compliance for Class 3 FDA and EU IVDR standards....Senior- A leading pharmaceutical company is hiring a Sr. Regulatory Specialist for a fully remote position. This role requires a Ph.D. in Biomedical Science and expertise in regulatory affairs, particularly in IVD product development. The specialist will collaborate with R&D teams...Remote jobSeniorFlexible hours
- ...their engineering team, working on medical devices for patient care. Responsibilities include research, design, testing, and regulatory compliance. Candidates should have a... ...the healthcare sector. This role may offer remote work possibilities with required travel. Benefits...Remote jobSenior
- MillenniumSoft Inc in San Antonio, TX, is seeking a Senior Project Manager to oversee the... ...candidate will have experience in the medical devices industry and be proficient in stakeholder... ..., and communication. The role is remote with limited travel required. #J-18808-Ljbffr...Remote jobSenior
- Medline Industries, LP is seeking a Senior Regulatory Specialist to manage critical... ...have at least 4 years of regulatory affairs experience in the medical device industry. Additional benefits include... ...insurance and a supportive work environment. #J-18808-Ljbffr Remote JobsRemote work
$145k - $155k
.... Medical Writer Peripheral Vascular Med Device (U.S. Remote) Position Overview This is a Temp-To-... ...: Collaborating with the clinical & regulatory teams to write clinical documents for... ...the Clinical, Medical, & Regulatory Affairs Teams, KOLs and physician investigators...Remote jobSeniorTemporary workInterim role- A leading life sciences company is seeking a Senior Regulatory Affairs Manager to lead their dynamic team through global clinical trials. The role involves driving submission planning, ensuring compliance with regulatory authorities, and managing multiple priorities. Candidates...Remote jobSenior
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