Senior Regulatory Affairs Leader - Cardio Medical Devices
BrioHealth Solutions
BrioHealth Solutions is seeking a skilled and self-motivated Senior/Principal Regulatory Affairs Specialist to support the BrioVAD® Left Ventricular Assist System. This individual will partner with cross-functional teams to support product development activities, US and EU clinical studies and regulatory planning and submission activities. You will prepare, review, and maintain FDA submissions, provide regulatory guidance, and monitor changes in U.S. #J-18808-Ljbffr BrioHealth Solutions
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...seeking a skilled and self-motivated Senior Regulatory Affairs Specialist to support the BrioVAD® Left... ...Partner with Clinical, R&D, Quality, Medical Affairs, and other cross-functional teams... ...communications, labeling, device changes, and other study-related documentation...SeniorMedical device- MannKind Corporation in Burlington, MA is seeking an Associate Director, Regulatory Affairs to coordinate regulatory review and approval of commercial materials, represent Regulatory on MRC and PRC, and lead interactions with FDA OPDP for respective products. The role...Senior
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...experience in a law firm. Responsibilities also include ensuring compliance with patent rules and supporting internal clients. The position offers a salary range of $160,000 to $190,000 and benefits such as medical insurance and a 401k plan. #J-18808-Ljbffr UNAVAILABLESeniorMedical device- A medical device company in Cambridge, MA, is seeking a Regulatory Affairs professional to lead regulatory strategies for Class II medical devices. Responsibilities include managing FDA submissions, ensuring regulatory compliance throughout product development, and collaborating...SeniorMedical device
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Job Title Senior Quality Operations Manager-Advanced Imaging Job... ...ensuring compliance with regulatory standards and operational excellence... ..., and regulatory affairs to address process gaps and... ...in FDA regulated (ISO 13485) medical device quality operations/manufacturing...SeniorMedical deviceFull timeWork at officeLocal areaImmediate startWork visaRelocation package3 days per week- ...Services in Morristown, NJ / Cambridge, MA is seeking a Senior Manager, Regulatory Affairs Advertising and Promotion to lead independent review of... ...requires a life sciences degree and 3+ years in pharma/medical device ad and promo review, with strong cross-functional #J-1...SeniorMedical device
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- What You’ll DoThe Senior Quality Assurance Specialist provides quality assurance oversight... ..., ensuring compliance with global regulatory requirements and internal quality standards... ...understanding of pharmaceutical and medical device Quality Management Systems.• Experience...SeniorMedical deviceFull timeContract workImmediate start
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Senior Software Quality EngineerThe Senior Software Quality Engineer position is responsible... ...of domestic and international quality/regulatory standards related to our... ...A minimum of 8 years of experience in medical devices, pharmaceuticals, diagnostic industry,...SeniorMedical deviceWork experience placement$111.75k - $167.5k
...role in bringing innovative medical technologies to market? As a... ...Procurement New Product Introduction Leader, you will be the key... ...R&D, Quality, Manufacturing, Regulatory, Marketing, and Supply Chain... ...regulated industry such as medical devices, pharmaceuticals, or...SeniorMedical deviceFull timeFlexible hours- Sector: Medical TechnologyReference: BBBH186741_1788363174 Shape the Future of Medical Device Innovation We're seeking a talented and detail... ...in compliance with global regulatory requirements, industry standards... ...to market. The Role As a Senior Design Assurance Engineer,...SeniorMedical device
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