International Registration Coordinator

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PMT Corporation located in Chanhassen Minnesota is known for manufacturing and distributing high end innovative products within the Orthopedic Neurosurgery and Plastic Surgery markets. Our workplace is a community of innovators who are passionate about creating an impact. We recognize that the collective power of our team is what propels us forward. Together we celebrate successes learn from challenges and continuously evolve in our pursuit of excellence.

Join us at PMT Corporation if youre ready to be a part of a collaborative idea-driven and communicative environment. Your 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 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.

DUTIES OF THE REGULATORY COORDINATOR (include but not limited to):

• 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

QUALIFICATIONS:

• Bachelors degree in Life Sciences or a related field.
• 13 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.
• Experience working with international product registrations and familiarity with regulatory submissions preferred

PMT is an Equal Opportunity Employer