The Regulatory Affairs Specialist is responsible for assisting in preparing regulatory submissions, listings, registrations, licensing, periodic updates and technical dossiers for domestic and international regulatory bodies. This position will help maintain regulatory documentation, product technical files, and participate in global teams to provide regulatory strategy and guidance.
Collect and coordinate information and assist in the preparation of regulatory documentation for submission to regulatory agencies following the submission strategy
Timely compilation of materials for license renewals, updates and registrations
Maintain regulatory files/database and chronologies in good order. Maintain system for tracking changes in documents submitted to agencies or partners
Assist with registration, listing, technical dossiers, MDD/MDR certification to ensure that the product information and certificates are maintained and accurate.
Maintains on-going surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems.
Review international shipment requests to ensure regulatory requirements are met.
Maintain regulatory documentation to ensure current product information is available for regulatory team, cross functional team members.
Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products
Education: 4 years college degree required.
Experience: 2 to 6 years of experience in medical device industry.
Computer literate and proficient in Microsoft Office Suite. CAD, Visio and other software experience is desired but not required.
Hands on experience with Windchill software preferred.
Ability to maintain confidentiality of information and materials.