Regulatory Affairs Specialist

Responsibilities: Providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified medical devices. ssist in the development of the regulatory strategies for new products and design changes - ensuring regulatory requirements for target markets are met. Preparing and submitting regulatory submission documents for US and OUS regulatory filings under minimal supervision for the EU and supporting outside of US (OUS) geographies. Represent Regulatory Affairs on assigned project teams through all phases of product development and communicate regulatory requirements. Prepare Technical Files /Design Dossier, Change Notifications, and Submissions (e.g. Documentary Audits under MDD/ MDR). Provie guidance and direction to ensure international product registration/licensing requirements are addressed and met before commercial release to maintain international product registrations. Responsible for ensuring compliance with all relevant quality system regulations, including EU MDR Regulation, ISO 13485:2016, 21 CFR Part 820, and the Regulations applicable for MDSAP certification. Prepare documentation that is complete, accurate, and on time. Utilizing detailed, in-depth understanding of regulations, interprets regulations, and provides regulatory guidance to product development teams. ctively participates in defining customer requirements, product claims, and target markets early in the product development lifecycle. Requirements: Direct experience with preparing Pre-Submission and interfacing with FDA personnel. Excellent knowledge and experience with global medical device regulatory requirements, design control, and product registration. Working knowledge of product development process. bility to assess the changes to marketed products and their impact on product registration. bility to identify, research, analyze technical documentation, and interpret governmental regulations. Excellent oral and written communication skills. Serve as regulatory liaison and work in cross-functional product development team. Capable of handling multiple tasks/projects and managing priorities accordingly. Effective interpersonal/communication skills. Works well under pressure in a dynamic timeline-driven environment. Extensive experience with MS Word and EXCEL. Regulatory Affairs Certification (RAC) preferred.

Created: 2024-11-05