Regulatory Coordinator

PMT Corporation•Chanhassen, MN

1d•Onsite

About The Position

The Regulatory Coordinator supports both the International Sales and Regulatory Affairs teams in obtaining and maintaining product registrations for medical devices in global markets. This role ensures compliance with international regulatory requirements and assists in preparing, organizing, and submitting documentation to regulatory authorities. This position is an on-site position at our Chanhassen, MN offices, Monday-Friday, 8am – 4:30pm.

Requirements

Bachelor’s degree in Life Sciences, or a related field.
1–3 years of experience in regulatory affairs, preferably in the medical device or healthcare industry.
Basic understanding of international regulatory requirements (e.g., EU MDR, FDA, Health Canada, MDSAP, etc.).
Strong organizational skills and attention to detail.
Ability to manage multiple projects and deadlines simultaneously.
Excellent written and verbal communication skills.
Knowledge of quality management systems (ISO 13485, ISO 9001, FDA QMSR, MDSAP)
Proficiency in Microsoft Office and document management systems.

Nice To Haves

Experience working with international product registrations and familiarity with regulatory submissions preferred

Responsibilities

Assist in the preparation and submission of international product registration dossiers.
Compile, review, and maintain regulatory documentation in accordance with country-specific requirements.
Track registration timelines, approvals, renewals, and changes across multiple regions.
Coordinate with internal teams (e.g., Quality, R&D, Marketing) to gather necessary documentation.
Communicate with international regulatory authorities, distributors, and partners as needed.
Maintain regulatory databases and ensure accurate record-keeping.
Prepare and process notarizations, apostille, or authentication of certificates with the State of Minnesota, or Department of State (US).
Support post-market regulatory activities, including report (PSUR, PMS) generation and updates, renewals, amendments, and compliance updates.
Monitor changes in international regulatory requirements and communicate updates to the International Sales and Regulatory Teams.
Support the International Sales Team and Regulatory Affairs by assisting with audits and inspections by organizing and providing required documentation.
Support with gap analysis, as requested from Regulatory Affairs or Quality Department
Assist in the review and updates of International Manuals, Patient Guides, and Product Forms and required translation updates
Create and provide updates on registration renewal schedules, supplying monthly reports to Vice President and International Sales Team
Act as secondary support for product barcode labeling system, understanding all aspects of processes and software
Other duties and responsibilities as assigned. Duties, responsibilities and activities may change at any time with or without notice