Global Regulatory Affairs Specialist - Medical Devices
AtriCure
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 will work with FDA, EU Notified Bodies, and Health Canada to ensure timely approvals, while collaborating with cross-functional teams on product development and regulatory compliance. #J-18808-Ljbffr
- ...Medtronic Regulatory Affairs Specialists lead worldwide product registrations with Geography Regulatory partners and global agencies. They provide expert advice, prepare submissions,... ...timely market access. The role requires medical device experience, FDA/EU submissions...Medical deviceWorldwide
$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- ...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...Medical device
- ...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... ...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
$113.03k - $165.77k
...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- ...Senior Regulatory Affairs Specialist – Medical Devices About the Role We are seeking a Senior Regulatory Affairs Specialist to support global regulatory activities for medical devices. This role partners with cross‑functional teams to develop regulatory strategies, prepare...Medical device
$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- ...Doist is seeking a highly experienced Regulatory Affairs Specialist to lead global post-market regulatory compliance efforts for medical devices. The role requires deep knowledge of U.S. and international regulations, with emphasis on incident reporting, CAPA, recalls...Medical device
$120k - $180k
...start here. Medtronic is a global leader in healthcare technology... ...— developing innovative medical technologies that improve... ...extraordinary. The Principal Regulatory Affairs Specialist will play a key role in... ...regulatory life cycle of medical devices and strong working...Medical deviceFull timeH1bWork at officeLocal areaImmediate startWorldwideFlexible hours$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$131k - $143k
...Why Join Bracco Medical Technologies? We care as much about... ...the Role The Principal Regulatory Affairs Specialist develops and executes regulatory... ...strategies for medical device products, submissions, and... ...changes 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
- ...The Regulatory Affairs Specialist will play a key role in supporting regulatory strategy and compliance... ...product lifecycle. Reporting to the Global Product Director, this individual... ...regulatory strategies supporting Class II medical devices throughout the product lifecycle....Medical deviceInternshipWork at office
- ...Regulatory Affairs Specialist Our client, a leader in the healthcare industry, is seeking 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
$70k - $110k
...Shift Type Job Title Regulatory Affairs Specialist II Education Bachelor's Degree Location... ...: Stereotaxis is the global leader in innovative robotic technologies... ...3-5 years' experience in regulated medical device industry highly preferred. • Knowledge...Medical deviceFull timeWork at officeShift work$88k - $130k
...Regulatory Affairs Specialist Date: Jul 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
$71k - $112k
...The Regulatory Affairs Specialist I supports regulatory activities to help ensure Philips... ...Image Guided Therapy Devices are safe, effective, and compliant with applicable global regulatory requirements. This... ...to develop expertise in medical device regulations, including...Medical deviceFull timeWork at officeLocal areaWork visaRelocation package3 days per week$74.4k - $111.6k
...Regulatory Affairs Specialist Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate... ...— developing innovative medical technologies that improve... ...and changes to existing devices and documentation....Medical deviceH1bWork at officeLocal areaImmediate startWorldwideFlexible hours$94k - $150k
Job TitleGSQ QMS Leader (Global)Job DescriptionGlobal Supplier Quality (GSQ) QMS Leader... ...Supplier ecosystems within a regulated medical device environment. This role will lead cross-... ...units. Ensure consistent adoption, regulatory compliance, and sustained audit readiness...Medical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week$74.4k - $111.6k
...start here. Medtronic is a global leader in healthcare technology... ...- developing innovative medical technologies that improve... ...worldwide, Role Overview The Regulatory Affairs Specialist develops strategies for... ...and changes to existing devices and documentation. Provide...Medical deviceH1bWork at officeLocal areaImmediate startWorldwideFlexible hours$88k - $130k
...Regulatory Affairs Specialist This is a mid-level Regulatory Affairs position responsible for integrating... ...changes to commercially distributed medical devices Conduct appropriate research to... ...the impact of changing and evolving global regulations on submissions,...Medical deviceTemporary workWork at officeFlexible hours- ...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
$113.3k - $226.7k
...AmericaTime Type: Full timeAbbott is a global healthcare leader that helps people... ...businesses and products in diagnostics, medical devices, nutritionals and branded generic... ...closely with R&D, Clinical, Medical Affairs, Regulatory, Health Economics, and regional commercial...Medical deviceWorldwideShift work$120.49k - $192.78k
...Principal Regulatory Affairs Specialist Join RespirTech's team in Plymouth, MN as... ...you will develop and execute global regulatory strategies for... ...innovative airway clearance therapy devices, enhancing product... ...experience within FDA regulated Medical Device environments, with a...Medical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week- ...Medtronic plc is seeking a Senior Regulatory Affairs Specialist to lead worldwide product registrations... ...to the FDA, EU MDR, and other global agencies, and collaborating with cross... ...global regulatory strategy for high-risk medical devices, leveraging your experience to...Medical deviceWorldwide
$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- ...leading contract research organization is looking for a Senior Regulatory Affairs Manager in Minneapolis, MN. The role involves managing... ...a Master's degree and have 7–10 years of experience in the medical device industry, with a strong track record in obtaining 510(k) approvals...Medical deviceContract work
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