International Medical Device Regulatory Coordinator
PMT Corporation
PMT Corporation in Chanhassen, MN, is seeking a Regulatory Coordinator to support International Sales and Regulatory Affairs in obtaining and maintaining medical device registrations worldwide. This on-site role runs Monday–Friday, 8am–4:30pm, and requires coordinating with Quality, R&D, and Marketing to gather documentation. You will manage submission timelines, maintain regulatory databases, and assist with post-market activities, audits, and translations. #J-18808-Ljbffr PMT Corporation
- ...innovation matters, and together, we can continue to shape the future of the medical device industry. REGULATORY COORDINATOR OVERVIEW: The Regulatory Coordinator supports both the International Sales and Regulatory Affairs teams in obtaining and maintaining product...InternationalRegulatoryMedical deviceWork at officeMonday to Friday
- ...center of product quality and regulatory excellence. In this role,... ...teams, helping ensure their devices meet the highest standards... ...documentation, labeling, compliance, international standards, and real... ...Desired Profile: * 1+ year in medical devices OR engineering/...InternationalRegulatoryMedical device
- EPM Scientific seeks a Principal Regulatory Affairs Specialist to lead global regulatory... ...for a portfolio of dental drug and medical device products. You will steer regulatory activities... ..., R&D, Clinical, Marketing, and international teams to support product launches and...InternationalRegulatoryMedical deviceRemote jobWorldwide
- ...CFR part 820 requirements as well as Medical Device industry practices to positively influence... ...applicable industry standards, other regulatory requirements, and customer... ...PowerPoint required.Ability to travel, both Internationally and Domestically 20-30% of time.Demonstrated...InternationalRegulatoryMedical deviceContract workWork at office
$131k - $143k
...Why Join Bracco Medical Technologies? We care as much about our... ...the Role The Principal Regulatory Affairs Specialist develops... ...regulatory strategies for medical device products, submissions, and... ...of FDA regulations, EU MDR, international regulatory frameworks,...InternationalRegulatoryMedical device$200k - $220k
...(with approximately 20% domestic and international travel). At Global Ops Strategy and PMO... ....Significant experience in diagnostic/medical device regulated environment (manufacturing,... ...in the Medical Device or Diagnostics regulatory environmentExcellent leadership, communication...InternationalRegulatoryMedical deviceHourly payFull timeRemote workWork from homeFlexible hours- ...of innovative, high-quality medical products focused on... ...processes in adherence to regulatory and internal requirements. Duties and Responsibilities... ...and distribution. Coordinate document retrieval requests... ...Knowledge of the medical device industry and the FDA and ISO...InternationalRegulatoryMedical device
$78.54k - $107k
...assurance standards and global regulatory requirements. Lead software... ...and firmware follow recognized international standards and regulations applicable to medical devices through the product lifecycle... ...quality requirements, and coordinate qualification testing. Collaborate...InternationalRegulatoryMedical deviceFull timeTemporary workWork at officeWorldwide- Job Description: Highly experienced Principal Regulatory Affairs Specialist to lead and support global post-market regulatory... ...ideal candidate will possess deep knowledge of U.S. and international medical device regulations, strong analytical capabilities, and the ability...InternationalRegulatoryMedical device
$78.54k - $107.1k
...requirements, quality standards, and regulatory requirements. The engineer independently... ...supporting FDA, ISO 13485, and international regulatory submissions. - Ensure verification... ...environment. - Hearing aid, medical device, or audio/consumer electronics experience...InternationalRegulatoryMedical deviceFull timeTemporary workWork at officeWorldwide- 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...InternationalRegulatoryMedical device
- Integer Holdings is seeking a senior regulatory affairs professional to develop and manage US and international regulatory strategies for medical device submissions. You will prepare submissions, interact with FDA/other agencies, and serve as a cross‑functional regulatory...InternationalRegulatoryMedical device
- AtriCure, Inc. in Minnesota seeks a Senior Regulatory Affairs Specialist to originate and... ...marketing privileges across US and international markets. You will submit 510(k), PMA supplements... ...requires regulatory expertise for medical devices, strong technical writing, and ability...InternationalRegulatoryMedical device
- AtriCure, Inc. in Minnesota is seeking a Senior Regulatory Affairs Specialist to manage regulatory submissions for US and international markets. You will prepare 510(k) submissions, PMA supplements, and global change documents, serving as regulatory lead on product development...InternationalRegulatoryMedical device
- PDDN INC. is seeking a Principal Regulatory Affairs Specialist to lead post-market regulatory... ...requires deep knowledge of FDA and international regulations, plus the ability to drive... ...2+ years in regulatory affairs within medical devices, strong communication skills, and...InternationalRegulatoryMedical device
- ...Principal Regulatory Affairs Specialist Elucent Medical is a medical device company focused on developing surgical navigation... ...of EU MDR and other international regulatory frameworks is preferred... ...Responsibilities: Prepare, coordinate, compile, and support submission...InternationalRegulatoryMedical deviceFull timeTemporary workLocal areaFlexible hours
- ...ICH standards. The role requires 5+ years in clinical data management within medical devices, HIPAA and regulatory knowledge, and experience with SAS, eCRFs, eTMF, and CDISC standards to ensure data quality across US and international trials. #J-18808-Ljbffr Itlearn360InternationalRegulatoryMedical device
$94k - $150k
Job TitleSenior Regulatory Affairs SpecialistJob DescriptionSenior... .... Responsibilities include coordinating and preparing regulatory... ...Declarations of Conformity, and Medical Device Licenses—for various global... ...is strongly preferred. International submissions experience is a...InternationalRegulatoryMedical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week$149.3k - $298.7k
...businesses and products in diagnostics, medical devices, nutritionals and branded generic... ...access to:Career development with an international company where you can grow the career... ...Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food...InternationalRegulatoryMedical deviceFor contractors- ...this timeAbout the Role The Regulatory Affairs Specialist I supports... ...activities throughout the medical device lifecycle. Working under the... ...product development cycle. Coordinate and compile team inputs and... ...regulatory applications and internal regulatory file documentation...InternationalRegulatoryMedical deviceHourly payInternshipWork at officeLocal areaShift work3 days per week
- ...and support, where necessary, device sales in a capital equipment... ...all applicable quality and regulatory guidelines as an integral... ...demonstrated success selling medical products or services to physicians... ...Regulations, and all other international regulatory requirements with...InternationalRegulatoryMedical deviceFull timeTemporary workLocal areaHome officeNight shift
$80k - $120k
...supervision, the individual in this role assists with medical writing and regulatory documentation, including preparation and... ...change requests. Monitor and analyze domestic and international medical device regulations to ensure submission requirements remain...InternationalRegulatoryMedical deviceFull timeWork at office$17.85 - $35.75 per hour
...healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000... .... You’ll also have access to : Career development with an international company where you can grow the career you dream of. Employees...InternationalMedical deviceHourly payWorldwide$78k - $156k
...businesses and products in diagnostics, medical devices, nutritionals and branded generic... ...access to:Career development with an international company where you can grow the career... ...Environmental Management Systems (EMS), and other regulatory requirements.Complies with U.S. Food...InternationalRegulatoryMedical deviceFor contractorsWorldwide- ...Global Cardiology Group as a Global Medical Director. Boston Scientific was... ...and Development (R&D), Quality, Regulatory Affairs and Commercial teams to support... ...providers, investigators and internal teams to evaluate adverse events, device performance trends and emerging...InternationalRegulatoryMedical deviceHourly payWork at officeWorldwideShift work
$113.3k - $226.7k
...businesses and products in diagnostics, medical devices, nutritionals and branded generic... ...access to:Career development with an international company where you can grow the career... ...downstream analytics, reporting, and regulatory submission requirements.Lead continuous...InternationalRegulatoryMedical device- Job Title: Regulatory Affairs Specialist II Location: Minneapolis, MN 55401, US (Primary... ...represent Stereotaxis Regulatory with international regulators on submission reviews/... .... 3-5 years' experience in regulated medical device industry highly preferred. Knowledge...InternationalRegulatoryMedical deviceFull timeWork at office
$160k - $180k
Senior Manager of Quality and Regulatory Plymouth, MN55441 Posted: 07/09/2026... ...$160,000 - $180,000 + Bonus Industry: Medical Device and Healthcare Technology --- About the... ...technology, developing FDA-cleared and internationally certified medical devices used in...InternationalRegulatoryMedical devicePermanent employmentContract workLocal areaWorldwideFlexible hours- ...role:The Sourced Finished Medical Device (SFMD) organization at Boston... ...with cross-functional internal/external resources to continually... ...and technical discussions. Coordinates the evaluation of proposed... ...to assess compliance with regulatory standards and Boston Scientific...InternationalRegulatoryMedical deviceHourly payShift work
$88k - $130k
...Regulatory Affairs Specialist This is a mid-level Regulatory... ...the product lifecycle and coordinating projects effectively. The role... ...to commercially distributed medical devices Conduct appropriate... ...documentation as requested by International Regulatory Affairs personnel...InternationalRegulatoryMedical deviceTemporary workWork at officeFlexible hours
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