Global Regulatory Affairs Specialist, Medical Devices
Coloplast
Coloplast is seeking a Regulatory Affairs Specialist to manage day-to-day regulatory tasks for medical devices across assigned geographies. You will prepare submissions, monitor status, and support post-market surveillance, change analysis, and vigilance reporting while ensuring design history file documentation stays current. The role requires 3+ years in regulatory affairs within the medical device industry, familiarity with FDA and EU regulations, and CE marking/Health Canada experience is a #J-18808-Ljbffr Coloplast
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Global Regulatory Affairs Specialist, Medical Devices in Minneapolis, MN vacancy
- Stereotaxis in Minneapolis, MN seeks a Regulatory Affairs Specialist II to support new product marketing approvals and renewals... ...background with 3-5 years in regulated medical devices and a working knowledge of global regulatory requirements. #J-18808-Ljbffr StereotaxisMedical device
- AtriCure, Inc. is seeking a Regulatory Affairs professional based in Minnesota to manage global regulatory submissions and maintain documentation required for marketing privileges. The role ensures compliance with government requirements and supports distributors and customers...Medical deviceWorldwide
- AtriCure, Inc. is seeking a Regulatory Affairs professional to originate and maintain marketing privileges with global regulators, and to manage documentation for international distributors and customers. The role also supports pre-market submissions (IDE, PMA, 510(k))...Medical device
- ...Abbott Laboratories in the United States seeks a Principal Regulatory Affairs Specialist to join Abbott’s Vascular Division on-site in St. Paul, MN. The role focuses on global regulatory submissions, ensuring product compliance and timely market approvals. As an experienced...Medical device
Abbott Laboratories company
New Brighton, MN1 day ago - ...AtriCure, Inc. in Minnesota seeks a Senior Regulatory Affairs Specialist to originate and maintain marketing... ...submit 510(k), PMA supplements, and global filings, while guiding regulatory... ...requires regulatory expertise for medical devices, strong technical writing, and...Medical device
AtriCure
Minnetonka, MN3 days ago - Laborie Medical Technologies is seeking a Regulatory Affairs Specialist for a hybrid role in Minnetonka, MN. You will support global product registrations and lifecycle maintenance for the US,... ...engineering and 1-3 years’ medical device regulatory experience are required...Medical device
- Stereotaxis, Inc. is seeking a Regulatory Affairs Specialist II to provide hands-on support for new product marketing approvals and renewals.... ...MN facility, contributing to the compliance and quality efforts in medical device development. #J-18808-Ljbffr Stereotaxis, Inc.Medical deviceWork at office
- ...Electrophysiology business in Plymouth, Minnesota, seeks a regulatory affairs specialist to prepare documentation for regulatory submissions in... ...comprehensive career development and competitive benefits, including medical coverage and retirement plans. #J-18808-Ljbffr AbbottMedical device
- VDYNE is a clinical-stage medical device company focused on transcatheter valve solutions for tricuspid regurgitation. We seek a Regulatory Affairs Specialist to support global regulatory activities across a growing portfolio and collaborate with Clinical, Quality, R&D...Medical device
- Job Description: Highly experienced Principal Regulatory Affairs Specialist to lead and support global post-market regulatory compliance activities within... ...possess deep knowledge of U.S. and international medical device regulations, strong analytical capabilities, and...Medical device
$107.2k - $160.8k
...left: 17px; padding-top: 15px; } he Regulatory Affairs Specialist is responsible for day-to-day regulatory... ...experience in regulatory affairs in Medical Device industryFamiliarity with FDA and EU... ...ethical integrityOpen-minded with a global mindsetEmbraces cultural differences...Medical deviceWork at officeLocal areaImmediate startFlexible hours$92k - $138k
...start here. Medtronic is a global leader in healthcare technology... ...— developing innovative medical technologies that improve... ...looking for a passionate Senior Regulatory Affairs Specialist who has direct experience... ...and changes to existing devices and documentation. Support...Medical deviceFull timeH1bLocal areaImmediate startWorldwideFlexible hours- ...Regulatory Affairs Specialist II - (RAS2.1) Company Description Stereotaxis is the global leader in innovative robotic technologies designed to enhance the treatment of arrhythmias... .... 3‑5 years’ experience in regulated medical device industry highly preferred. Knowledge of...Medical deviceWork at office
Stereotaxis
Minneapolis, MN3 days ago - Abbott is seeking a Regulatory Affairs Specialist II to work on-site in Plymouth, MN. This role requires strong attention... ...skills while preparing and supporting global regulatory activities for implantable medical devices. With 2-3 years of experience in a regulated...Medical device
- AtriCure, Inc. seeks a Senior Regulatory Affairs Specialist to originate and maintain marketing privileges across US and international markets. This role will prepare submissions and support regulatory strategies for new product development and post-market changes. You...Medical device
- ...Saluda Medical is a commercial‑stage medical device company focused on developing treatments for chronic neurological... ...’s lives. As a Principal Regulatory Affairs Specialist, you will provide Regulatory... ...regulatory strategies, prepare global regulatory submissions and...Medical device
Saluda Medical
Minneapolis, MN8 hours ago - ...the healthcare industry, is seeking a Regulatory Affairs Specialist to join their team. As a Regulatory... ...Affairs Department supporting global post-market compliance activities. The... ...Regulatory Affairs and/or Quality within the medical device, healthcare, or life sciences...Medical deviceWeekly payTemporary workFlexible hours
ManpowerGroup Global, Inc.
Minneapolis, MN4 days ago $131k - $143k
...Why Join Bracco Medical Technologies? At Bracco Medical... ...where experienced regulatory professionals can influence global product strategy, partner... ...The Principal Regulatory Affairs Specialist develops and executes regulatory... ...strategies for medical device products, submissions,...Medical deviceBracco Medical Technologies
Minneapolis, MN2 days ago$94k - $150k
...Senior Regulatory Affairs SpecialistThe Senior Regulatory Affairs Specialist for Ultrasound collaborates with regulatory teams and authorities to secure... ...Files, Declarations of Conformity, and Medical Device Licenses—for various global markets.Support cross-functional teams...Medical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per weekPhilips
Minneapolis, MN3 days ago$120.49k - $192.78k
...Principal Regulatory Affairs SpecialistJoin RespirTech's team... ...Principal Regulatory Affairs Specialist, where you will develop and execute global regulatory strategies... ...clearance therapy devices, enhancing product development... ...within FDA regulated Medical Device environments,...Medical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per weekPhilips
Minneapolis, MN2 days ago$85k - $104k
...Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment... ...FUNCTIONS OF THE POSITION: Support global regulatory pre-market applications for geographies... ...(Change Control) Work with Regulatory Affairs staff, engineers and technical experts...Medical deviceContract workTemporary workFor contractorsFor subcontractorWork at officeLocal areaRemote workWorldwideAtriCure
Minneapolis, MN3 days ago- Saluda Medical is a commercial‑stage medical device company focused on developing treatments for chronic neurological... ...Reporting to the Sr. Director, Regulatory Affairs, the Senior Regulatory Affairs Specialist will provide input to global regulatory strategies and support...Medical device
$61.3k - $122.7k
Abbott is a global healthcare leader that helps people live more fully at all stages... ...and products in diagnostics, medical devices, nutritionals and branded generic medicines... ...seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in...Medical deviceFlexible hours$50.7k - $101.3k
Abbott is a global healthcare leader that helps people live more... ...products in diagnostics, medical devices, nutritionals and branded generic... ...of documentation for regulatory registration, ensuring products... ...Device industry. Regulatory Affairs Professionals Society Certification...Medical deviceFor contractorsWork experience placementWorldwide$61.3k - $122.7k
...Employees can qualify for free medical coverage in our Health... ...a passionate, experienced Regulatory Affairs Specialist II to join our team on-site... ...preparation and general support of global regulatory activities. This... ...implantable medical devices is preferred. What You’ll...Medical deviceWork at officeShift work$61.3k - $122.7k
Abbott is a global healthcare leader that helps people live more fully at all stages... ...and products in diagnostics, medical devices, nutritionals and branded generic medicines... ...seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in...Medical deviceFor contractorsWork experience placementWorldwide$129.5k - $203.5k
...that are essential in everyday technology devices from smartphones to electric vehicles, or... ...like Spectrum and Liveo, we advance global health through innovation.We are hiring a... ...skillsPreferred ExperienceCardiovascular or medical device market experienceGlobal / cross-cultural...Medical deviceRemote work$200k - $275k
A medical technology company based in Plymouth, Minnesota, is seeking a Global Software Leader for Acute Products/Devices. This role requires significant experience in device software engineering, managing a globally distributed team, and a strong understanding of medical...Medical device- ...in Plymouth, MN is seeking an External Manufacturing Leader to drive end-to-end management of a global third-party manufacturing network in a highly regulated medical device environment. You will lead CMOs, strengthen infrastructure, and ensure supply continuity, quality...Medical device
- Philips seeks an External Manufacturing Leader to drive execution across a global third-party manufacturing network in a highly regulated medical device environment. You will strengthen infrastructure, elevate operational rigor, and build scalable processes across a global...Medical device
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Regulatory Affairs Specialist, Medical Devices. Be the first to apply!
Related searches
- regulatory affairs specialist Minneapolis, MN
- medicare compliance specialist Minneapolis, MN
- senior compliance analyst Minneapolis, MN
- regulatory compliance analyst Minneapolis, MN
- compliance specialist Minneapolis, MN
- aml compliance analyst Minneapolis, MN
- regulatory officer Minneapolis, MN
- healthcare compliance officer Minneapolis, MN
- regulatory analyst Minneapolis, MN
- regulatory specialist Minneapolis, MN