Global Regulatory Affairs Specialist - Medical Devices
AtriCure
AtriCure, Inc. in Minnesota seeks a Senior Regulatory Affairs Specialist to originate and maintain marketing privileges across US and international markets. You will submit 510(k), PMA supplements, and global filings, while guiding regulatory strategy on new products and post-market changes. You’ll collaborate with cross-functional partners to ensure timely approvals and compliance. The role requires regulatory expertise for medical devices, strong technical writing, and ability to travel #J-18808-Ljbffr
- 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
- 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
$94k - $150k
Job TitleSenior Regulatory Affairs SpecialistJob DescriptionSenior Regulatory Affairs Specialist, UltrasoundThe Senior Regulatory Affairs Specialist for... ...Files, Declarations of Conformity, and Medical Device Licenses—for various global markets.Support cross-functional...Medical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week- ...Regulatory Affairs Specialist We believe that great healthcare is an essential safeguard... ...with Passion. Laborie Medical Technologies is currently... ...Specialist will support global product registration, approval... ...Affairs in the medical device industry ~1-3 years' experience...Medical deviceWorldwideFlexible hours
$106k - $130k
...Synergy Ablation System is the first medical device to receive FDA approval for the... ...personally. POSITION SUMMARY The Senior Regulatory Affairs Specialist originates appropriate documents to... ...personnel on assessing and documenting the global impact of product change on product...Medical deviceTemporary workWork experience placementWork at officeLocal areaWorldwide$106k - $130k
...Synergy™ Ablation System is the first medical device to receive FDA approval for the... ...personally. POSITION SUMMARY: The Senior Regulatory Affairs Specialist originates appropriate documents to... ...on assessing and documenting the global impact of product change on product...Medical deviceContract workTemporary workFor contractorsWork experience placementFor subcontractorWork at officeLocal areaWorldwide- 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
- ...job is to strategically plan, execute and provide oversight to regulatory activities necessary to obtain and maintain regulatory... ...related field.Minimum Experience: 7+ years of US and International medical device regulatory submission/approval experience, to include FDA,...Medical deviceFull timeImmediate start
- ...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&...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- ...GroveDiversity - Innovation - Caring - Global Collaboration - Winning Spirit -... ...highly skilled and experienced Principal Regulatory Affairs Specialist to join our Interventional Oncology... ...Affairs and/or Quality within the medical device industry, including a minimum of 3...Medical deviceHourly payWork at officeLocal areaShift work3 days per week
- ...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
$131k - $143k
...Why Join Bracco Medical Technologies?We care as much about our... ...About the RoleThe Principal Regulatory Affairs Specialist develops and executes... ...regulatory strategies for medical device products, submissions, and... ...to existing devices, global registrations, audits, labeling...Medical device- ...center of product quality and regulatory excellence. In this role, you... ...regulatory teams, helping ensure their devices meet the highest standards and are ready for global markets. If you love variety,... ...Profile: * 1+ year in medical devices OR engineering/startup...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
$165.55k - $260.15k
...essential in everyday technology devices from smartphones to electric... ...processes across Spectrum’s global Healthcare manufacturing... ...meet critical-to-quality (CTQ), regulatory, and customer requirements.Operational... ...experience, ideally in the medical device manufacturing industry...Medical deviceFlexible hours- ...VDYNE is a clinical-stage medical device company focused on developing innovative transcatheter... ...achieve these ambitious goals. THE ROLE As a Regulatory Affairs Specialist at VDyne, you'll support regulatory operations and global clinical and commercial regulatory...Medical deviceWork at officeShift work
- ...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
$88k - $130k
...Regulatory Affairs Specialist Date: Aug 25, 2026 Location: Maple Grove, MN, US Company:... ...About Teleflex Incorporated As a global provider of medical technologies, Teleflex is driven... ...commercially distributed medical devices • Conduct appropriate research to...Medical deviceTemporary workWork at officeFlexible hours- ...Senior Regulatory Affairs Specialist Work mode: Hybrid Onsite Location(s): Marlborough... ...- Innovation - Caring - Global Collaboration - Winning... ...positive relationships with device reviewers through oral and... ...related discipline within the medical device industry, including...Medical deviceWork at officeLocal area3 days per week
- ...Job Description Job Description Partners Personnel has partnered with a global leader in medical device manufacturing to hire Production Assemblers for a long-term opportunity in Minnetonka, MN. Whether you have manufacturing experience or are looking to start a new...Medical deviceShift workDay shiftAfternoon shift
$99.3k - $198.7k
...HealthcarePosted Date: 2026-09-03Abbott is a global healthcare leader that helps... ...and products in diagnostics, medical devices, nutritionals and branded generic... .... This role partners with Medical Affairs, Clinical Affairs, Regulatory Affairs, Quality, R&D, Marketing,...Medical deviceWorldwide$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
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$113.3k - $226.7k
...Type: Full timeAbbott is a global healthcare leader that helps... ...and products in diagnostics, medical devices, nutritionals and branded generic... ...with Clinical and Med Affairs teams to drive our podium and... ...product developmentPartner with regulatory colleagues in the review and...Medical deviceLocal areaWorldwideShift work- ...verification/validation within a regulated medical device environment.Roles & Responsibilities:... ...from cross-functional inputs (regulatory, quality, manufacturing, service, etc.)... ...automotive, military)Experience working with global, cross-functional teamsBachelor's or Master...Medical device
- ...AtriCure, Inc. seeks a Senior Regulatory Affairs Specialist to prepare and submit regulatory documents (510(k), PMA, EU/Canada/Japan) to support... ...agencies. Requirements: Bachelor’s degree, 4+ years in medical device regulatory affairs, strong writing and communication...Medical deviceWorldwide
$150.5k - $236.5k
...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
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