Senior Regulatory Affairs Leader - Medical Devices (510(k))
EndoFix Medical Technologies, Inc.
Endofix Medical is a small, innovative medical device company developing advanced endoscopic surgical devices. We are seeking a Senior Regulatory Affairs Specialist to lead regulatory activities across the product lifecycle and provide strategic guidance onsite in Massachusetts. The successful candidate will partner with development, quality, manufacturing and commercial teams, manage 510(k) submissions, and interact with FDA and European Notified Bodies to support clearances, labeling, and #J-18808-Ljbffr EndoFix Medical Technologies, Inc.
- ...Senior Regulatory Affairs Specialist – Onsite Endofix Medical is a small, innovative medical device company developing advanced endoscopic surgical devices. We are seeking an experienced... ...regulatory submissions, including 510(k)s for Class II medical devices, as well as...SeniorMedical deviceContract work
- Siemens Healthineers in the United States is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions and lifecycle documentation for medical devices and IVDs. You will serve as a regulatory expert, guide design control activities, and collaborate with...SeniorMedical deviceRemote job
$169.58k - $233.18k
...unique contributions. As a Senior Director, Program... ..., Marketing, Quality, Regulatory Affairs, Manufacturing, Supply... ...will serve as a trusted leader who enables executive... ...a global, regulated medical device environment from program... ...vision insurance 401(k) retirement plan life...SeniorMedical deviceTemporary workWork at officeLocal area- ...Senior Software Engineer Veranex's mission as an Innovation CRO is to improve patient... ..., preclinical and clinical research, regulatory affairs, and market access and reimbursement... ...in delivering software for innovative medical device products. You'll lead technical...SeniorMedical deviceRemote work
$109.25k - $149.5k
...portfolio of leading medical devices. Ensure that the... ...with auditees and senior management while... ...procedures and the regulatory and legislator requirements... ...Chain, Regulatory Affairs, Product Development, and business leaders as required or... ...savings plan (401(k)).Subject to the...Medical deviceFull timeTemporary workWork experience placement$80.9k - $127.05k
...Full time 20186058 What Regulatory Affairs contributes to Cardinal Health... ...to enable pharmaceutical, medical and biotechnology companies... ...registrations, including FDA 510(k) submissions, EU Technical Documentation... ...regulatory and medical device requirements. Monitor,...Medical deviceFull timeTemporary workWork experience placementLocal areaImmediate startRemote workFlexible hours$120k - $180k
...Medtronic is a global leader in healthcare technology... ...developing innovative medical technologies that... ...the LifeThe Principal Regulatory Affairs Specialist will play a... ...for Wound Management devices. Sustaining regulatory... ...regulationsPrepare Pre-Sub and 510(k) submissions and...Medical deviceFull timeH1bWork at officeLocal areaImmediate startWorldwideFlexible hours$192.05k - $263.35k
...Description SummaryThe Senior Director, Supplier... ...consistently meet regulatory, quality, and... ...decision making.This leader will define and... ...&D and Regulatory Affairs to ensure product... ...Quality within the medical device or regulated life... ...savings plan (401(k)).Subject to the terms...SeniorMedical deviceFull timeContract workTemporary work$200k
...site 1x per week, hybrid. We're hiring a Senior Software Engineer to take the reins on... ...quality-management-system environments (medical device, pharma, or defense), or communication protocols... ...benefits: health, dental, vision, 401(k) with 50% match up to 6% of base salary,...SeniorMedical deviceImmediate start$81.65k - $112.7k
...Senior Process EngineerJoining us is a chance to do important work that... ...ISO 13485, EU MDR, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies.ResponsibilitiesWorks within... ..., and savings plan (401(k)).Subject to the terms of their...SeniorMedical deviceTemporary workWork at office- ...Senior Design Assurance Engineer Veranex's mission as an Innovation... ...and clinical research, regulatory affairs, and market access and... ...improve lives globally through medical technology innovation. The Design... ...novel and existing medical devices, including risk management...SeniorMedical deviceFull timeWork experience placementWorldwideFree visa
$81.65k - $112.7k
...system (Trackwise preferred).Experience in regulated environment; medical device or pharma preferredFamiliarity with health, safety, and... ...accident insurance, and group legal insurance, and savings plan (401(k)).Integra LifeSciences is an equal opportunity employer, and is...SeniorMedical deviceTemporary work$50 - $70 per hour
...and developing high-quality software for medical devices used in laboratory, hospital, and remote... ...high standards of quality and regulatory compliance.Essential SkillsBachelor's degree... ...Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post...SeniorMedical deviceContract workTemporary workWork at officeRemote work$147.76k - $203.17k
Regulatory Affairs Professional page is loaded## Regulatory Affairs Professionalremote... ...notices and supplements, 510(k) submissions and notes to... ...standards applicable to medical device market clearance.*... ...more than 70 countries. As a leader in medical technology, we constantly...Medical deviceTemporary workWork at officeLocal area- ...manufacturing engineering for sutures and related devices. The role emphasizes design controls, regulatory compliance, and cross‑functional collaboration to meet... ...position requires a BS in engineering, 4+ years in medical devices, and experience leading projects. #J-18808...SeniorMedical device
- ...week, more if desired) Nature of Role The Senior Software Engineer is based at Nabsys’... ...Management System (QMS), as is common in Medical Device, Defense, or other regulated industries.... ...Benefits include health, dental, vision, 401(k) plan with 50% match up to 6% of base...SeniorMedical device
- ...mentor statistical programmers. You will develop SAPs, randomization schedules, and study outputs while ensuring data quality and regulatory compliance. Responsibilities include collaboration with clients and clinical teams, development of analysis datasets and tables,...SeniorRemote job
- Siemens Healthineers in the United States seeks a Senior Director, Program Management to lead large, complex Systems and Informatics... ...cross-functional leadership across R&D, Marketing, Quality, Regulatory Affairs, Manufacturing, Supply Chain, Service, and Operations to...SeniorMedical device
$23.6 - $29.5 per hour
...technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose... ...required Knowledge, Skills and AbilitiesPrevious group leader experience preferred Excellent supervisory and communication...Medical deviceHourly payMinimum wageOngoing contractFull timeWork at officeLocal areaRemote workWorldwideShift workNight shift- ...Join Our Team at Tegra Medical!We're a trusted contract manufacturer for some of the biggest names in the medical device industry. Known for taking on complex projects that others... ...'re shaping the future of healthcare.The Senior Manufacturing Engineer develops, implements...SeniorMedical deviceContract workWork at office
$135k - $145k
...patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and...SeniorMedical deviceMinimum wageOngoing contractWork at officeLocal areaRemote workWorldwide- ...Validation, Calibration, Materials, Quality Control, and Logistics. The role emphasizes documentation reviews, batch release, and collaboration with external entities like contractors, suppliers, and customers to ensure regulatory compliance. #J-18808-Ljbffr OrganogenesisSeniorMedical deviceFor contractors
$140k - $190k
PENN Entertainment is seeking a senior finance leader to direct the Finance department, develop and manage budgets, ensure regulatory compliance, and drive financial reporting... ...Rewards package including day-one medical coverage, 401(k) matching, and an #J-18808-Ljbffr Socket...- ...Position Summary The Senior Account Manager, Regulated & Medical Markets, is responsible for... ...technical, quality, and regulatory expectations that shape buying... ..., and other critical device components.... ...closely with Regulatory Affairs, Technical Service, Product...SeniorMedical deviceFull timeContract workWork at officeLocal areaRemote work
$151k - $215k
...everything we do. As part of our Medical Affairs team, you'll foster internal... ...inspiring journey. The Senior Principal Biostatistician (... ...clinical trial designs to regulatory submissions while applying scientific... ...for (Preferred): Medical device industry experience strongly...SeniorMedical deviceFull timeRemote work$96.75k - $145k
...takes the limits off living.Step into a senior level role where your expertise will... ...continuous improvement in a highly regulated medical device environment. Based in Mansfield, MA,... ...ratesEnsure compliance with applicable regulatory and quality standards including ISO 134...SeniorMedical deviceFull timeFlexible hours$156k - $234k
...Medtronic is a global leader in healthcare technology... ...developing innovative medical technologies that improve... ..., and progress to senior leadership.SPECIALIZED... ...architectures for connected devices, edge computing, mobile... ...: Incentive plans, 401(k) plan plus employer contribution...SeniorMedical deviceFull timeWork experience placementH1bWork at officeLocal areaImmediate startFlexible hours$95.5k - $115k
...patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and...SeniorMedical deviceMinimum wageOngoing contractH1bLocal areaRemote workWorldwideRelocation- ...and maintain design control documentation for combination drug-device and biologic products, including Design History Files (DHF). Ensure... ...or related discipline. 5-10 years of experience in a regulated medical device or combination product environment. Experience with...SeniorMedical device
- A leading technology company is seeking a Compliance Officer to support its Third Party Assessments within Compliance Programs & Operations. The role involves advising on aspects of the Third-Party Management Program and conducting due diligence on third parties. Candidates...Senior
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