International Regulatory Specialist Audubon, PA Position Summary: The International Regulatory Specialist will be responsible for drafting, submitting, and gaining approval of product registrations and other submissions to international regulatory agencies. Essential Functions: • Work in conjunction with other departments to develop submissions; • Partner with Product Development, Quality Assurance, and management to prepare and review international regulatory submissions including CE technical files and design dossiers, and other international filings, to obtain marketing clearance; • Obtain timely marketing clearance for all products in parallel with US submissions; • Provide regulatory oversight of changes in manufacturing facilities, processes, and procedures, as they pertain to international regulations; • Coordinate, review and submit product labeling for marketing outside the U.S.; • Review design changes and technical files for updates to documentation; • Prepare and file certificates to foreign governments with FDA; • Develop relevant regulatory SOPs as necessary; and • Ensure conformance to International Organization for Standardization (ISO), Conformité Européenne (CE), Food & Drug Administration (FDA) and other international/local regulations. • Up to 10% domestic and international travel required to visit hospitals, medical buildings, customer sites, etc. Qualifications: • Requires a Bachelor's degree or foreign equivalent in engineering or a relevant scientific field (Biology, Chemistry, Physics, Pharmacy, etc.) or related field; • 5 years of experience in a related occupation; • Experience ensuring compliance with U.S. FDA and international regulatory requirements; • Experience providing expert regulatory guidance to development project teams, contributing to the formulation of comprehensive regulatory strategies for innovative medical devices and new product introductions; • Experience evaluating proposed product and process changes to determine their impact on regulatory status across U.S. and global markets; • Experience researching and analyzing regulatory requirements; • Experience offering regulatory feedback for various transfer and remediation projects; • Experience coordinating and contributing to the preparation and submission of Technical Documentation for EU MDR submissions, including significant change notifications; • Experience performing detailed regulatory gap assessments to identify compliance deficiencies and recommending corrective actions in line with current industry and regulatory standards; and • Experience preparing key regulatory deliverables, including Letters to File (LTF), Regulatory Release Memos, and Regulatory Analyses for FDA 510(k)-cleared products. #LI-DNI Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.