Responsibilities:

• Maintenance of domestic and foreign regulations and quality standards
• Works with and responds to inquiries from regulatory agencies.
• Respond to product questionnaires from customers.
• Maintains Technical Files in compliance with the European Medical Device Directive
• Prepare and provide regulatory information and documents needed for product import or export.
• Collaborate with Sales and Marketing personnel to identify global regulatory requirements for international product registrations.
• Issuance of certificates of origin and/or conformity as requested.
• Request FDA Certificate to Foreign Government, Certificate of Exportability as needed
• Process document legalization, authentication and apostille as needed.
• Support the preparation and submission of product applications and license amendments to Health Canada.
• Provide support, create, and maintain documents, correspondence, memorandums, etc. pertinent to Quality Assurance and Regulatory Affairs activities
• Maintain Establishment Registrations, Device Listings and State Licenses

Requirements:

• Minimum 5 years knowledge and experience in Regulatory Affairs and Quality Assurance in the manufacture of sterile, disposable medical devices
• B.S. in Business or a related technical field preferred
• Strong understanding of FDA Quality System Regulations, Medical Device Directive, and ISO 13485 regulations
• Proven ability to maintain ongoing compliance in a regulated environment.
• Able to organize and maintain detailed regulatory and quality records/documentation.
• Excellent written and verbal communication skills
• Works well independently and as a team member
• Knowledge and/or experience in internal and external quality audits
• Has a desire to function as a team member by listening, asking questions, collaborating, and contributing on daily basis.
• Organized and able to perform in a time-sensitive environment.
• Comfortable with prioritizing and managing multiple assignments.
• Demonstrates a flexible and collaborative approach with various cross-functional teams.
• Able to draw on diplomatic communication skills.