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/Principal Regulatory Affairs Specialist to support the BrioVAD®... ...Partner with Clinical, R&D, Quality, Medical Affairs, and other cross-functional... ...investigator communications, labeling, device changes, and other study-related...SeniorMedical device
$134k - $213k
Senior Quality Operations Manager-Advanced Imaging### Job DescriptionThe... ...ensuring compliance with regulatory standards and operational... ..., and regulatory affairs to address process gaps and... ...in FDA regulated (ISO 13485) medical device quality operations/manufacturing...SeniorMedical deviceFull timeWork at officeLocal areaWork visaRelocation package3 days per week- ...manufacture, and distribution of innovative medical devices and pharmaceutical products. You will... ...inspections to ensure compliance with regulatory and company requirements.Drive supplier... ..., Manufacturing, R&D, Regulatory Affairs, and Quality teams to support product quality...SeniorMedical deviceLocal area
- Philips in Bedford, MA, seeks a Senior Quality Operations Manager to oversee strategic... ...will lead a quality team and ensure regulatory standards and QMS compliance across NPI... ...role requires 10+ years in FDA-regulated medical device quality operations, with at least 3+ years...SeniorMedical device
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$197k - $243k
...of a wide range of therapeutics without medical sharps or refrigeration. Terrestrial has... ...We are building from scratch. We need a senior leader who can own that build — and then own... ...Preferred Biotech, pharma, or medical device background strongly preferred Experience...SeniorMedical device- Quanterix is seeking an experienced Senior Manager, Tax to lead global tax operations from Billerica, MA in a hybrid environment. This role partners with Accounting, SEC Reporting, Treasury, Legal, and external advisors to drive compliant, scalable tax processes and clear...Senior
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$90k - $180k
...Abbott is a global healthcare leader that helps people live more... ...products in diagnostics, medical devices, nutritionals and branded generic... ...60 countries. Job Title Senior Electrical Engineer, Medical... ...feasibility and formal regulatory submission Contribute to...SeniorMedical deviceFor contractorsRemote workWorldwide$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$163k - $196k
...information, visit Position Purpose: The Senior Manager/Associate Director, Legal... ...implementations, and evolving legal or regulatory requirements Required Skills & Experience... ...Pharmaceutical, biotechnology, medical device, or life sciences experience Effective...SeniorMedical deviceContract workTemporary workWork at officeShift work$122.25k - $176.58k
Job Title: Senior Manager, Regulatory Affairs Advertising and Promotion Location: Morristown, NJ / Cambridge... ...Committees (RC) for commercial and medical materials, respectively. Provides guidance... ...within pharmaceutical or medical device advertising and promotional review....SeniorMedical deviceWork experience placement$147.4k
Posting Description SENIOR LICENSING AND BUSINESS DEVELOPMENT OFFICER, Technology Licensing Office, is responsible for the commercialization... ...therapeutic, diagnostic, drug delivery, genetic engineering, medical device, biomanufacturing, biomaterials and/or drug discovery...SeniorMedical deviceFull timeWork at officeVisa sponsorship- ...-scale, cross-functional software programs from concept to commercial release, align strategies with product roadmaps, and drive regulatory-compliant delivery. You will mentor program managers, manage budgets, and partner with executives to optimize investments. Strong...SeniorMedical device
$220k - $290k
...difference in people's lives. Our medical devices, software and related... ...conditions.Job SummaryThe Senior Director, Chief Privacy Lead... ...) serves as the enterprise leader responsible for the... ...stakeholders across Legal, Regulatory Affairs, IT, Cybersecurity, R&D, Clinical...SeniorMedical deviceMinimum wageOngoing contractFull timePrivate practiceLocal areaRemote workWorldwide$110k - $120k
...Description About Lexington Medical Lexington Medical designs... ...engineering, manufacturing, regulatory and quality work together under... ...it. About the Role As a Senior Quality Systems Specialist at... ...S. and international medical device requirements. Partner with...SeniorMedical device- Real is seeking a Sr. Global Product Manager in Billerica, MA to lead global product strategy within the medical devices sector and drive innovative solutions that improve healthcare outcomes. This permanent role offers ownership of end-to-end product lifecycle and collaboration...Medical devicePermanent employment
- ...Philips in Bedford, MA seeks an Innovation Program Management Leader for Advanced Imaging to lead a complex medical device platform program spanning hardware, electronics, software, regulatory readiness, manufacturing readiness, service readiness, and launch execution...Medical device
$107k - $130k
...Senior Process Engineer Location: Woburn, Moving to Allston in Q4, 2026, Onsite... ...of a wide range of therapeutics without medical sharps or refrigeration. Terrestrial has... ...hands-on R&D experience within the medical device or biopharmaceutical industries; experience...SeniorMedical device$120k - $135k
LeMaitre in Burlington, Massachusetts is seeking a Research and Development Engineer focused on medical devices, particularly implantable biologic materials. The role includes responsibilities such as supporting the current biological product portfolio, conducting research...SeniorMedical device$184k - $292k
...Innovation Program Management Leader - Advanced Imaging (Bedford,... ...development program for a regulated medical equipment platform that... ...to deliver phased releases, regulatory and operational readiness, and... ...a strategic complex medical device platform program spanning hardware...Medical deviceFull timeWork at officeWork visaRelocation package3 days per week- What You’ll DoThe Senior Quality Engineer is responsible for supporting the effective... ...human factors/usability engineering of medical devices, as well as driving continuous improvement... ...system to ensure compliance with regulatory requirements. This individual collaborates...SeniorMedical deviceFull timeWork at officeImmediate start
$78k - $156k
...Employees can qualify for free medical coverage in our Health... ...The Opportunity The Senior Software Design Assurance Engineer... ...FDA regulations, other country regulatory requirements, company policies... ...medical software and non-medical device software development. ~...SeniorMedical deviceWork experience placement$137k - $215.27k
...constrained supply."ACCOUNTABILITIES:The Senior Manager, Planning Lead will be a... ...and in-country investigational product regulatory requirements for delivery of product to... ...experience is preferred.Experience with Medical Devices a plus.Ability to influence stakeholders...SeniorMedical deviceMinimum wageContract workLocal area
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