Regulatory Affairs Specialist

General Position Summary Responsible for promoting awareness and adherence to regulatory requirements for the Company's products and services, ensuring compliance with domestic and international regulations through the most efficient means. Collaborates with various internal departments, including Quality, Engineering, R&D, Customer Operations, Sales, and Marketing, as well as external stakeholders such as customers and suppliers, throughout pre-production, production, and post-production phases. Develops and implements procedures and practices in accordance with applicable regulations, maintaining the company's quality system policies, procedures, and processes. Offers recommendations, contributions, and support for monitoring regulations, standards, and system implementation. Contributes to all aspects of the Quality Systems and Validation Department. The Regulatory Affairs Specialist guides the internal team through intricate domestic and international regulatory landscapes, working closely with external government and regulatory authorities and diverse internal stakeholders. Emphasizes attention to detail and technical expertise to ensure products meet regulatory requirements before distribution and throughout the device's lifecycle, actively participating in the completion and maintenance of regulatory approvals and clearances for assigned products. Essential Job Functions Regulatory Affairs Specialist Activities - Orchestrates the coordination and preparation of document packages and dossiers for regulatory submissions within and beyond the U.S. - Actively engages in project teams, contributing regulatory strategy, timelines, and deliverables. - Manages global regulatory submissions and ongoing responsibilities, ensuring thorough reviews of changes to ensure compliance with new standards. - Supports the formulation of a global regulatory strategy for post-market changes, encompassing aspects like design, manufacturing, and labeling. - Assists in GUDID submissions. - Represents the regulatory function in manufacturing and product development teams, providing regulatory insights for product lifecycle planning. This involves: - Strategizing and presenting alternatives for meeting regulatory requirements, both within regulatory affairs and cross-functionally. - Resolving conflicts between regulatory requirements and development issues. - Escalating complex situations to management for guidance and training opportunities. - Overseeing documentation packages for submission to global regulatory agencies. - Tracking timelines and documenting milestone achievements for inclusion in regulatory submissions. - Assisting in interactions with regulatory agencies, including submission review and on-site audit support (e.g., FDA inspections for future 510(k)s, IVDR audits related to CE marking design dossiers and technical documentation). - Providing guidance on regulatory requirements is essential for contingency planning. - Monitoring proposed and current global regulations and guidance, assessing their impact on assigned projects, and proposing suggestions for leveraging regulatory updates to expedite the approval process. - Reviews labeling content, product and process changes, and product documentation to ensure compliance, consistency, and accuracy with regulatory requirements. - Collaborates with cross-functional teams to define the scope and assess strategies for managing the entire product lifecycle, including pre-market development and post-market changes. Applies design control principles and regulatory knowledge to guide teams through successful regulatory reviews. - Assists in developing regional regulatory strategy and adapts strategies based on regulatory changes for medical devices. - Anticipates and navigates regulatory obstacles based on information from international agencies and trends in the regulatory environment. - Determines and communicates submission and approval requirements, monitoring applications under reg…