Global Regulatory Affairs Specialist - Medical Devices
Synergy Spine Solutions
Synergy Spine Solutions Inc. in Louisville, CO seeks a mid-level Regulatory Affairs Specialist to manage global regulatory lifecycle for the Synergy Disc and future spine devices. On-site in Louisville, CO with hybrid options, you will coordinate submissions, strategies, and post‑market obligations across markets. You will collaborate with R&D, Quality, Clinical, and commercial teams, maintain technical files, respond to FDA and international inquiries, and monitor EU MDR and ISO standards for #J-18808-Ljbffr
- ...time Reports to: Vice President, Regulatory Affairs & Quality Assurance ABOUT SYNERGY... ...SOLUTIONS Synergy Spine Solutions is a medical device company focused on improving the... ...a mid-level Regulatory Affairs Specialist to support the global regulatory lifecycle of the...Medical deviceFull time
$78k - $85k
...Regulatory Affairs SpecialistThe Regulatory Affairs Specialist supports our product teams supporting new product... ...in vitro diagnostic devices containing both software... ...devices per local and global regulations.· Provide regulatory... ...actions.· Support medical device reporting, post-...Medical deviceFull timeWork at officeLocal areaFlexible hoursAfternoon shift- ...This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems...Medical deviceWork at office
- ...Responsibilities: The Associate Regulatory Affairs Manager will support the... ...regulatory documents for medical device and IVD products. This role... ...FDA, ISO 13485, and other global regulatory requirements. The... ...mentorship to junior staff or specialists on assigned projects....Medical deviceWork at office
$195k - $220k
...brighter way forward. As Global Technical Engineering Lead... ...operational excellence and regulatory compliance of a large-scale... ...production of life-saving medications and medical devices by maintaining critical... ...Engineering, and Regulatory Affairs teams to align building maintenance...Medical deviceFull timeContract workFor contractorsWork at officeLocal area- Highridge Medical LLC located in Westminster, Colorado, is seeking an Associate Buyer Planner to develop and manage demand planning forecasts... ...in related fields, and preferences for APICS certification and medical device background. #J-18808-Ljbffr Highridge Medical LLCMedical deviceWork at office
- ...Senior Risk Management Quality EngineerMedtronic, a global leader in medical technology, services, and solutions, is seeking a... ..., product development, design controls and regulatory compliance within the medical device industry. This position requires a strong team player...Medical device
- ...start here. Medtronic is a global leader in healthcare technology... ...— developing innovative medical technologies that improve the... ...including: marketing, sales, regulatory affairs, quality, research and development... ...health and connected-device initiatives, advising digital...Medical deviceWork at office
- ...established quality, reliability, and regulatory requirements throughout the product lifecycle... ...information, please review Insight Global's Workforce Privacy Policy: Skills... ...electronics, aerospace, semiconductor, medical device, or advanced manufacturing environments...Medical device
- ...Preferable experience in the medical or scientific software field.... ...solutions. Experience writing for a global audience. Experience with... ...design controls for medical devices, including requirements,... ...Marketing, Product Development, and Regulatory groups. Identify IFU...Medical device
- ...Operations AnalystQuest Global delivers world-class end-to-end engineering solutions by leveraging our deep industry knowledge and... ...& defense, automotive, energy, hi-tech, healthcare, medical devices, rail and semiconductor industries.We are looking for humble...Medical deviceFull timeRemote work
$215k - $256.8k
...Supply Chain, R&D, Commercial, Quality and Regulatory to improve existing processes for new and mature products. Leverage global offshore teams, providing technical... ...as the design and development of capital medical devices. Navigate the complexities of various government...Medical deviceRelocation package$110k - $145k
...ideas to life—from advancing space exploration and life‑saving medical devices to building autonomous electric vehicles. With 3,000+ experts... ..., commercial vehicles, EVs, rail, and more. As part of the global ALTEN Group—57,000+ engineers in 30 countries—we deliver...Medical device$145.92k - $192k
...and a shared commitment to delivering solutions that strengthen global stability and security. Team members work side-by-side with... ...years of experience in a regulated industry (aerospace, robotics, medical device, automotive, or equivalent)Deep familiarity with MES (...Medical devicePermanent employmentWork at officeLocal areaWorldwideFlexible hours- ...Compliance Specialist Integrated Resources, Inc is... ...disseminate information from a global perspective. JOB... ...other international regulatory agencies. Works... ...~ BS in clinical/medical, Engineering or science... ...communication through automated devices such as the telephone....Local area
$76k - $114k
...EHS Specialist, Radiation SafetyOur Global Environmental, Health, Safety & Sustainability... ...activities for a medical device manufacturer. In this role... ...operations, quality, and regulatory teams to help ensure compliant... ...and Safety, Regulatory Affairs, Engineering, Life...Medical deviceH1bWork at officeLocal areaImmediate startWorldwideFlexible hours$80k - $110k
...Mechanical EngineerQuest Global delivers world-class end-to-end engineering solutions by leveraging our deep industry knowledge... ...aerospace & defense, automotive, energy, hi-tech, healthcare, medical devices, rail and semiconductor industries.We are looking for humble...Medical deviceTemporary workRemote workFlexible hours$76k - $114k
...EHS Specialist, Radiation Safety Our Global Environmental, Health, Safety & Sustainability... ...activities for a medical device manufacturer. In this role... ...operations, quality, and regulatory teams to help ensure compliant... ...and Safety, Regulatory Affairs, Engineering, Life...Medical deviceH1bWork at officeLocal areaImmediate startWorldwideFlexible hours- ...quality team. The role focuses on risk analysis, design controls, regulatory compliance, and patient safety across the product lifecycle.... ...ideal candidate has strong risk management experience in medical devices, ability to mentor teams, and a track record of improving...Medical device
$116.8k - $175.2k
...change lives start here. Medtronic is a global leader in healthcare technology with a Mission... ...patients first — developing innovative medical technologies that improve the lives of 72... ...software for next-generation medical devices, ensuring high performance, reliability,...Medical deviceTemporary workH1bWork at officeLocal areaImmediate startFlexible hours$124.8k - $187.2k
...change lives start here. Medtronic is a global leader in healthcare technology with a Mission... ...patients first — developing innovative medical technologies that improve the lives of 72... ...who have developed firmware for embedded devices and have experience working close to the...Medical deviceH1bWork at officeLocal areaFlexible hours- LivaNova, a global medtech company, is seeking a Laboratory Technologist to support testing and evaluation of medical devices within a GLP-compliant lab environment in Colorado. The role involves hands-on testing, instrument maintenance, and rigorous documentation to support...Medical device
- ...regulated environments such as pharmaceutical, biotechnology, or medical device manufacturing. This role ensures that systems including... ...applications are validated in compliance with FDA, EU, and global regulatory requirements. The Senior CSV Engineer will act as a subject...Medical device
- ...Sr Manufacturing Engineer Summary: Seeking a Sr Manufacturing Engineer to support implementation of design changes for medical device electronic hardware. The role focuses on process validation, test method validation, PLM/ERP management, manufacturing documentation...Medical device
- ...who goes beyond prescriptions to provide meaningful care with medication, TMS, and ketamine therapy in a calm, patient-centered setting... ...independently and as part of a team About Serenity Using advanced medical devices recently released to market, Serenity Healthcare provides long...Medical deviceFlexible hours
- ...Engineer to design, develop, test, and maintain mixed-signal medical device electronics for Surgical Innovations products (Energy Generators, Lung Health, GYN). Responsible for board-level design, regulatory compliance, verification, debugging, reliability, and product...Medical device
$102.9k - $128k
...technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose... ...to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature...Medical deviceMinimum wageOngoing contractFull timeH1bWork at officeLocal areaRemote workWorldwide$100k - $120k
...RWS as a trusted partner throughout the global clinical development lifecycle. Acting... ...solutions tailored to address the complex regulatory environment in force with premium... ...Sciences and Healthcare (pharmaceuticals, medical devices, CROs, healthcare companies), Finance (...Medical deviceContract workWork at officeLocal areaFlexible hours- ...development, ensuring alignment with regulatory and business requirements.... ...support for Investigational Device Exemptions (IDEs), pre-submissions, and other global regulatory filings. Lead cross-... ...in regulated environments (IVD, medical device, or similar). Background...Medical deviceWork at office
- Job Title: Package Assembler Client: Medical Device Manufacturing Company Duration: 12 Months (possible extension) Location: Louisville, CO 80027 Shift: Monday-Friday | 6:30 AM - 2:30 PM Additional: Mandatory overtime based on business needs Summary...Medical deviceImmediate startMonday to FridayShift work
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