Principal Regulatory Affairs Specialist

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Principal Regulatory Affairs Specialist based in United States. This is a senior regulatory affairs opportunity supporting the development, registration, and lifecycle management of medical device products across global markets. The role combines regulatory strategy, submission leadership, compliance, and commercial support across complex product portfolios. You will help shape regulatory approaches for new and modified products while ensuring requirements are embedded throughout the product lifecycle. Working across U.S., European, and international frameworks, you will influence market access and help navigate evolving regulatory expectations. The position offers significant autonomy, with responsibility for multiple projects and the opportunity to identify and resolve regulatory risks proactively. You will collaborate closely with cross-functional, regional, and global stakeholders in a technically sophisticated healthcare environment. This is an impactful role for an experienced regulatory professional who enjoys solving complex problems and accelerating compliant product access. Lead regulatory strategies for new and modified medical device products, integrating regulatory requirements throughout development and lifecycle activities. Prepare, submit, and maintain global product registrations, including FDA 510(k) submissions, EU Technical Documentation, International STEDs, and other applicable regulatory materials. Partner with global and regional regulatory teams to coordinate market-access strategies and ensure submissions and registrations are executed effectively and on schedule. Review product labeling and related materials to ensure alignment with applicable U.S., EU, and international medical device requirements. Monitor emerging regulations and regulatory trends, assess their potential business impact, and provide actionable guidance to stakeholders. Maintain regulatory intelligence, identify compliance risks, and develop mitigation strategies and practical solutions. Provide regulatory guidance for customer inquiries, bids and tenders, customs requests, OEM and private-brand activities, and other commercial initiatives. Develop, implement, and maintain regulatory procedures, SOPs, and compliance processes that support consistent execution and continuous improvement. Manage regulatory information, analytics, and reporting through regulatory information management systems, including trend analysis of submission activity. Ensure product and regulatory requirements are implemented and maintained effectively to support ongoing compliance and international market access. Independently manage multiple complex regulatory projects, providing strategic direction while proactively identifying risks, challenges, and business implications. Contribute technical expertise, innovative solutions, and mentorship to less experienced colleagues and cross-functional partners. Requirements Bachelor’s degree in a scientific discipline or equivalent professional experience; an advanced understanding of medical device regulatory affairs is highly valued. At least 5 years of regulatory affairs experience, preferably within the medical device industry. Strong knowledge of U.S. FDA medical device regulations and experience preparing International STEDs and technical documentation. Demonstrated experience developing regulatory strategies and managing submissions or registrations across multiple international markets. Strong understanding of regulatory compliance, product lifecycle requirements, labeling, and regulatory intelligence. Excellent organizational and project management skills, with the ability to manage multiple complex priorities while consistently meeting deadlines. Strong analytical, problem-solving, written, and verbal communication skills. Ability to work independently with general guidance while