Global Regulatory Affairs Specialist - Medical Devices
Medtronic plc
Medtronic plc in Lafayette, Colorado, together with other U.S. locations, is seeking a Regulatory Affairs Specialist to support regulatory documentation and lifecycle activities for medical devices. You will partner with product development, lifecycle teams, and quality to ensure compliance across markets. The role emphasizes regulatory submissions, change control, and ongoing regulatory monitoring, with opportunities to grow RAC certification and influence global submissions. #J-18808-Ljbffr Medtronic plc
- ...Medtronic plc is seeking a Regulatory Affairs Specialist within the Advanced Energy Operating Unit in the United States. You will support regulatory... ...changes, and maintain regulatory systems to ensure global compliance. You will partner with cross-functional teams,...Medical device
$120k - $180k
...start here. Medtronic is a global leader in healthcare technology... ...— developing innovative medical technologies that improve... ...Operating Unit. The Principal Regulatory Affairs Specialist (Pr. RAS) provides... ...Extensive experience inmedical device regulatory affairs. Strong...Medical deviceH1bWork at officeLocal areaFlexible hours$74.4k - $111.6k
...start here. Medtronic is a global leader in healthcare technology... ...— developing innovative medical technologies that improve... ...quality patient care. As a Regulatory Affairs Specialist in the Advanced Energy Operating... ...requirements for medical devices Familiarity with EU MDR,...Medical deviceH1bWork at officeLocal areaFlexible hours- ...We're actively seeking qualified candidates for the following position: Sr Regulatory Affairs Specialist Top Needs: 1. Medical device regulatory experience in change assessment with focus on US FDA and EU MDR 2. Experience with medical device manufacturing process...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$83k - $103.7k
...POSITION SUMMARY: The Sr. Regulatory Affairs Specialist is responsible for the preparation of regulatory... ...required to market new or modified medical devices and in vitro diagnostic devices in... ...OUR OPPORTUNITY Natera™ is a global leader in cell-free DNA (cfDNA) testing...Medical deviceWork at officeImmediate startRemote workWorldwide$85k - $110k
...future. Highridge Medical creates the world'... ...of medical devices, but if you have strong... ...teams to develop regulatory strategies and drive... ...compliance with applicable global regulations... ..., interns, and specialists Support additional... ...between Regulatory Affairs and other teams...Medical device- ...pediatric spine portfolio strategy, working with surgeons, R&D, regulatory, and field teams to deliver education, tools, and... ...clinical and commercial functions and requires navigating complex medical devices markets. The position focuses on upstream and downstream marketing...Medical device
- ...Medtronic in Lafayette, CO is seeking a Regulatory Affairs Manager to establish strategies for worldwide product approval and submission activities... ...EU regulatory compliance for Lung Health and Gynecologic devices. The role requires onsite work four days a week at specified...Medical deviceWorldwide
- ...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
- ...professional in Lafayette, CO. The role involves receiving failed medical devices, documenting receipts, and evaluating contaminated devices... ...data handling, and collaboration with production and quality teams to maintain regulatory compliance and quality #J-18808-LjbffrMedical device
- ...experience supporting senior leaders and managing complex calendars, travel, meetings, events, purchasing, invoices, and confidential information. xhyhwjd Experience in a regulated, medical-device, healthcare, manufacturing, or global matrix organization preferred....Medical deviceWork at office
$19.5 - $21 per hour
As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create... ...treat conditions — we aspire to alter the course of lives. Medical Device Production Assembler Build Products That Help Change Lives Arvada...Medical deviceFull timeWorldwide$35.72 - $46.16 per hour
...IIPrimary Location Lafayette, Colorado Facility Name Rock Creek Medical Offices Employee Status: Regular Worker Location: Onsite... ...oversight; and maintaining adequate parts of inventory for medical devices and software with limited oversight.Conducts ongoing preventative...Medical deviceFull timeWork experience placementShift work$154k - $174k
...company in Lafayette, Colorado, is seeking a Staff Embedded Software Engineer to design and develop embedded solutions for advanced medical devices. The ideal candidate will have over 10 years of experience in embedded software development, proficiency in languages such as C...Medical deviceFull time3 days per week$95k - $136k
Description: ABOUT US Cerapedics is a global, commercial-stage orthopedics company... ...worldwide. Cerapedics has two drug-device products approved by the FDA powered by Cerapedics... ...Experience with orthopedics or spinal medical devices is highly desirable. Aptitude...Medical deviceWork experience placementWork at officeWorldwide- ...functional team who is responsible for the development of new medical devices and systems in the Surgical Division to: Lead small and... ...plans and resource requirements, demonstrating adherence to global PMO practices and templates, e.g. on-boarding, kickoff meeting...Medical device
- ...qualify components and/or medical devices Strong supplier... ...experience Regulatory remediation or compliance... ...Quality, Regulatory Affairs, Manufacturing, Operations... ...: Insight Global is seeking a Principal... ...Principal Project Management Specialist for a top medical...Medical deviceFull timeContract work
- ...together to achieve shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active... ...) preferably in the biotech, life science, pharmaceutical, medical device or related industry – strong business-to-business selling experience...Medical deviceWork at office
- ...field with research and development experience in the medical device industry. ~5+ years of work experience in new... ...qualification, and transfer of manufacturing ... Regulatory Operations & Labeling Specialist Featured We are looking for a detail-oriented Labeling...Medical deviceTemporary workWork experience placement
- ...(eIFUs) within a regulated medical device environment. You will work extensively... ...-functional teams (R&D, Regulatory, Quality, Software Packaging... ...review workflows across global regulatory regions.... ...Partner with R&D, Regulatory Affairs, Quality Assurance, and Software...Medical deviceFull time
$88k - $110k
...boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility... ...product design role. Experience in healthcare, medical devices, or regulated industries preferred. Strong portfolio showcasing...Medical deviceFlexible hoursNight shift$25 - $32 per hour
...Engineering Test Technician supports a growing medical device contract manufacturing environment with... ...and adhere to all safety, quality, and regulatory guidelines in the manufacturing and... ..., CO.About ActalentActalent is a global leader in engineering and sciences services...Medical deviceContract workTemporary workCasual workShift work- ...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... ...time zones. Experience in the medical device, healthcare, life sciences, or other regulated...Medical deviceWork at officeLocal area
$18.5 - $21.5 per hour
...3rd Shifts AvailableAre you looking for a career with a company that makes a real difference in people's lives? Join a leading medical device manufacturer and help build precision surgical instruments used in life-changing laparoscopic procedures. This is a great opportunity...Medical devicePermanent employmentContract workTemporary workImmediate startShift workNight shiftDay shiftAfternoon shift$90k - $115k
...About Us Established in 1972, Particle Measuring Systems is a global leader for micro-contamination monitoring equipment improving... ...in capital equipment, ideally within pharmaceutical, biotech, medical device, or cleanroom manufacturing industries Strong technical aptitude...Medical deviceWork at officeLocal areaRemote workWork from homeHome officeNight shift$74.4k - $111.6k
## Regulatory Affairs SpecialistApply: Onsite: Lafayette, Colorado... ...here. Medtronic is a global leader in healthcare... ...innovative medical technologies that improve... ...a Regulatory Affairs Specialist in the Advanced Energy... ...requirements for medical devices* Familiarity with EU...Medical deviceFull timeH1bWork at officeLocal areaImmediate startFlexible hours- ...Actalent in Louisville, CO is seeking an Engineering Test Technician to support a medical device contract manufacturing environment, focusing on NPI and low-volume production. You will assemble and troubleshoot electromechanical systems and assist in test and calibration...Medical deviceContract work
- ...start here. Medtronic is a global leader in healthcare technology... ...- developing innovative medical technologies that improve the... ...impact. A Day in the Life As the Regulatory Affairs Manager, you will be... ..., new, and modified medical devices to meet business objectives,...Medical deviceLocal areaWorldwide
- ...Sciences in Westminster, CO is seeking a hands-on engineer-in-training to support the development and manufacturing of catheter-based medical devices. You will assist the engineering team with lab work, prototype assembly, and testing under FDA and ISO 13485 guidelines....Medical device
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