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
$131k - $143k
...Principal Regulatory Affairs Specialist Why Join Bracco Medical Technologies? We care as much about our employees... ...regulatory strategies for medical device products, submissions, and lifecycle... ...of FDA regulations, EU MDR, international regulatory frameworks, product lifecycle...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- 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
- 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
- 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
- Cypress HCM is partnering with a medical device manufacturer in the Twin Cities to hire a Senior Manager of Regulatory Affairs and Design Assurance. You will lead regulatory... ...leadership, directing lifecycle activities, managing international #J-18808-Ljbffr Cypress HCMInternationalRegulatoryMedical device
- ...plan, execute and provide oversight to regulatory activities necessary to obtain and... ...approvals within the United States and International markets and ensure compliance with relevant... ...: 7+ years of US and International medical device regulatory submission/approval experience...InternationalRegulatoryMedical deviceFull timeImmediate start
- A leading global medical device company is seeking an Associate Director of Regulatory Affairs to lead global regulatory strategy and execution for a rapidly expanding... ...filings (510(k), IDE, PMA, EU MDR/CE mark, international registrations) Assessing regulatory risks,...InternationalRegulatoryMedical 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$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- ...of Stereotaxis' systems have received regulatory clearance in the United States, European... ...Assurance Engineer directly supports medical device product development from concept... ...cGMP and MDD regulations/guidelines, and International Standards. *Experience with design verifications...InternationalRegulatoryMedical deviceFull timeWork at officeShift work
- A medical device manufacturing client is looking to hire a Senior Manager of Regulatory Affairs and Design Assurance in the Twin Cities. This... ...485, EU MDR, and relevant international standards. Develop and... ...service providers. Lead and coordinate regulatory inspections and...InternationalRegulatoryMedical deviceContract work
- 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
- ...Senior Mechanical EngineerSaluda Medical is a commercial-stage medical device company focused on developing treatments... ..., and usability files.Support regulatory filings and intellectual property... ...regulations (21 CFR 820.30) and international standards (IEC 60601-1)....InternationalRegulatoryMedical deviceContract work
- ...Job Description Job Description A medical device client is hiring a permeant Sr. Regulatory Specialist, onsite in Maple Grove, MN. This person will assist... ..., and labeling—to support IDE, PMA, and other international filings. An ideal candidate brings strong writing...InternationalRegulatoryMedical deviceWork at office
- ...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
$86.7k - $173.3k
...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... ...execute new US materials.Partner with regulatory colleagues in the review and negotiation...InternationalRegulatoryMedical deviceWorldwide- ...Who We’re Looking For: Laborie Medical Technologies is currently searching for a Regulatory Affairs Specialist to join our... ...States, Canada, Europe, and other international regions. This role is... ...Regulatory Affairs in the medical device industry 1-3 years' experience...InternationalRegulatoryMedical deviceWorldwideFlexible hours
$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- ...skilled and experienced Principal Regulatory Affairs Specialist to join... ....Manage communications with internal regulatory partners outside... ...bodies regarding recalls.Coordinate and manage Product Incident... ...Affairs and/or Quality within the medical device industry, including a...InternationalRegulatoryMedical deviceHourly payWork at officeLocal areaShift work3 days per week
- ...physician leadership role will provide medical expertise and strategic guidance... ...and Development (R&D), Quality, Regulatory Affairs and Commercial teams to... ...providers, investigators and internal teams to evaluate adverse events, device performance trends and emerging clinical...InternationalRegulatoryMedical deviceWorldwide
- ...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 and Boston Scientific requirements...InternationalRegulatoryMedical deviceHourly payShift work
- Saluda Medical is a commercial‑stage medical device company focused on developing treatments... ...lives. As a Principal Regulatory Affairs Specialist, you... ...development cycle while coordinating team inputs for... ...FDA regulations, EU MDR, international regulatory frameworks,...InternationalRegulatoryMedical device
$78k - $156k
...and products in diagnostics, medical devices, nutritionals and branded... ...Career development with an international company where you can grow... ...the team regarding global regulatory reporting decisions. Maintains... ..., organizing, performing, coordinating and/or directing workRemain...InternationalRegulatoryMedical deviceLocal areaWorldwideShift work$150k - $175k
...difference in people's lives. Our medical devices, software and related... ...consistent with legal and regulatory standards and company policies... ...of development.Manage internal teams, Contract Research Organizations... ...matters, often requiring coordination across functionsKnowledge,...InternationalRegulatoryMedical deviceMinimum wageOngoing contractFull timeContract workTemporary workWork at officeLocal areaRemote workWorldwideNight shift3 days per week$94k - $151.8k
...Sustainability SolutionThe Johnson & Johnson Medical Devices Companies (JJMDC) are committed to... ...efficiencies, personnel safety and regulatory compliance. Oversees timely completion... ...require up to 10% of domestic and/or international travelThe attendance policy required for...InternationalRegulatoryMedical deviceFull timeWork at officeLocal areaImmediate startRemote work$140k - $180k
ABOUT INSPIRE MEDICAL SYSTEMSInspire is the first of its kind medical device designed to make a difference in the lives of those... ...studies in accordance with internal standard operating procedures and... ...adverse events as required by regulatory bodies, reviewing adverse event...InternationalRegulatoryMedical deviceWork experience placementInterim roleLocal areaFlexible hours$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 contractorsWorldwideShift work
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