International Medical Device Regulatory Coordinator

PMT Corporation; Chanhassen (MN); On-site; USD 60,000 - 85,000; Full time

Job summary

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.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• 1–3 years in regulatory affairs, preferably in medical devices.
• Understanding of EU MDR, FDA, Health Canada, MDSAP.
• Strong organizational skills and attention to detail.
• Ability to manage multiple projects and deadlines simultaneously.
• Excellent written and verbal communication skills.
• Knowledge of ISO 13485, ISO 9001, FDA QMSR, MDSAP.
• Proficiency in Microsoft Office and document management systems.
• Experience with international product registrations and regulatory submissions.

Responsibilities

• Assist in preparation and submission of international product registration dossiers.
• Compile and maintain regulatory documentation per country requirements.
• Track timelines, approvals, renewals, changes across regions.
• Coordinate with Quality, R&D, Marketing to gather docs.
• Communicate with regulatory authorities, distributors, partners.
• Maintain regulatory databases and records.
• Prepare notarizations, apostilles for MN or US Dept. of State.
• Support post-market regulatory activities, including PSUR and PMS.
• Monitor regulatory changes and inform teams.
• Assist with audits and inspections by organizing documents.
• Support gap analysis as requested.
• Review International Manuals, Patient Guides, Product Forms; update translations.
• Create updates on registration renewal schedules; monthly reports to VP and Intl Sales.
• Act as secondary support for product barcode labeling system.
• Other duties as assigned.

Skills

Regulatory coordination

Regulatory submissions

Excellent communication

Organizational skills

Project management

Education

Bachelor’s degree in Life Sciences

Tools

Microsoft Office

Job description

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.