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
- ...Inc. 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 device
$92k - $138k
...start here. Medtronic is a global leader in healthcare technology... ...- developing innovative medical technologies that improve... ...Day in the Life The Senior Regulatory Affairs Specialist will play a key role in supporting... ...for Class II medical devices that include hardware and software...Medical deviceH1bWork at officeLocal areaWorldwideFlexible 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 Access and... ...regulatory requirements for medical devices Familiarity with EU MDR,...Medical deviceH1bWork at officeLocal areaImmediate startFlexible hours- ...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
$19.5 - $21 per hour
...As a global medtech company, we are driven by our Vision of changing the trajectory of lives... ...LivaNova! LivaNova is a global medical technology company built on nearly five... ...and advanced cardiovascular medical devices. We hire individuals who are looking for...Medical deviceWorldwideShift work- ...established quality, reliability, and regulatory requirements throughout the product lifecycle... ...information, please review Insight Global's Workforce Privacy Policy: Skills and... ...electronics, aerospace, semiconductor, medical device, or advanced manufacturing environments...Medical device
$131.2k - $196.8k
...here. Medtronic is a global leader in healthcare technology... ...developing innovative medical technologies that... ...the Clinical, Medical Affairs & HEPR (CMAH)... ...the CMAH team including regulatory agencies Lead audit... ...Experience in the Medical Device Industry. For Baccalaureate...Medical deviceFull timeH1bWork at officeLocal areaImmediate startFlexible hours$88.8k - $133.2k
...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... ...Nice to Haves Experience in the medical device industry and/or surgical techniques....Medical deviceFull timeH1bWork at officeLocal areaImmediate startWorldwideFlexible 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 deviceFull timeH1bWork at officeLocal areaImmediate startFlexible hours$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 deviceFull timeH1bWork at officeLocal areaImmediate startFlexible hours$65k - $75k
...Requirements POSITION: Operations Analyst Who We Are: Quest Global delivers world-class end-to-end engineering solutions by... ...& defense, automotive, energy, hi-tech, healthcare, medical devices, rail and semiconductor industries. We are looking for humble...Medical deviceFull timeWork experience placementRemote work$146k - $210k
...ABOUT US Cerapedics is a global, commercial-stage orthopedics... .... Cerapedics has two drug-device products approved by the... ...Operations working on the Clinical Affairs team, you will be... ...external stakeholders including Regulatory Affairs, Legal, Medical Affairs, Senior Leadership...Medical devicePart timeWork at officeImmediate startRemote workWorldwide- ...Contract Total Hours/week: 40.00 1st Shift Client: Medical Device Company Job Category: Engineering Level Of... ...Holders Only) No H1B’s Job Description Client is a global medical technology company that is focused on improving drug therapies...Medical deviceContract workH1bDay shift
$146k - $211k
...Description: ABOUT US Cerapedics is a global, commercial-stage orthopedics... .... Cerapedics has two drug-device products approved by the FDA... ...in a global pharmaceutical or medical device company Sunshine Act... ...working with Commercial and Medical Affairs functions Experience managing...Medical devicePart timeWork at officeImmediate startWorldwide$40 - $50 per hour
...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 deviceFull timeFor contractorsFlexible hours$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- ...designer of Cinch and Cruel, is seeking a Customs Compliance Specialist at our Denver, Colorado headquarters to support the company’s... ...documents, and coordinate with internal teams and customs brokers to ensure regulatory compliance and timely shipments. #J-18808-Ljbffr...
- ...Senior Mechanical Engineer (Medical Devices – Design & Sustaining Engineering... ...start here. Medtronic is a global leader in healthcare... ...combination of technical depth, regulatory discipline, and cross-functional... .... Technical Specialist Career Stream: An individual...Medical deviceWork at office
- ...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
$40 - $60 per hour
...as aerospace, defense, electronics manufacturing, robotics, medical devices, or automotive. Current IPC-A-610 and IPC-A-620 certification... ...role are also entitled to paid sick leave and/or other paid time off as provided by applicable law. #J-18808-Ljbffr Insight GlobalMedical device$95k - $105k
...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 deviceFor contractorsWork at officeLocal area$111.2k - $166.8k
...from Medtronic's acquisition of Aircraft Medical and combines the agility of a startup with... ...engineers, to help build the embedded device. You will contribute at the junction of user... .../reimbursement, and Simple Steps (global well-being program). The following benefits...Medical deviceH1bWork at officeLocal areaFlexible hours- ...validation, and product change control and have a strong foundation/working knowledge of FDA regulations and ISO standards for medical devices. Job Responsibilities: • Oversight of Non-conforming product dispositions and completions • Oversight of Process Validation...Medical device
$130k - $160k
...that the firm complies with all applicable regulatory requirements and protecting the firm... ...in implementing Partners Group's overall global compliance framework. Responsibilities... ...and wellness package, including medical, dental and vision coverage 401k (Roth...Full timeWork experience placementImmediate start- ...Job Title: Compliance Specialist Location: Louisville,... ...disseminate information from a global perspective. JOB... ...other international regulatory agencies. Works closely... ...: BS in clinical/medical, Engineering or science... ...communication through automated devices such as the telephone....Local area
$55 - $60 per hour
...$55.00 - $60.00/hr. Job 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$34 - $37 per hour
...in an Outpatient Clinic ~ Excellent benefits: We cover 90% of medical, dental & vision for you and your family ~401(k) – because... ...Referral Program Who We Are: Using advanced medical devices recently released to market, Serenity Healthcare gives our patients...Medical deviceHourly payShift workWeekend work$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- ...Louisville, CO Duration – 12+ Months Contract Client: Medical Device Company Employment Type: Contract on W2 (Need US... ...experienced team members Applies intermediate understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with...Medical deviceContract work
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