Regulatory Affairs Specialist Jobs in United States

Company Overview Function Health is the AI operating system for health, designed to empower people to live 100 healthy years. We are redefining how individuals understand, measure, and improve their health by moving beyond the limitations of traditional care and enabling comprehensive, continuous in

POSITION SUMMARYRegulatory Affairs Specialist for EMEA region responsible for all things Regulatory in the region, including but not limited to ingredient review, marketing collateral review, product registrations, and label reviews. Understands, implements, and maintains the quality policy. Ensures

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Pulse Biosciences (Nasdaq: PLSE): Join the Future of Bioelectric Medicine Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients. The Company’s proprietary CellFX® nsPFA™ (nanosecond Pulsed Field Abl

AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related co

Arcetyp LLC is a growing small business that provides a broad range of consulting services to US Federal Government, US Military, and Commercial clients. Services include Management & IT Consulting, Program & Project Management, and Professional & Admin Services. We accept direct hire candidates onl

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product—an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflo

In this role, you will work with the team that ensures that Penumbra products are approved for use in countries around the world, thereby helping to bring our life-saving technologies to patients worldwide. You will be responsible for the coordination, preparation, and maintenance of document packag

In this role, you will work with the team that ensures that Penumbra products are approved for use in countries around the world, thereby helping to bring our life-saving technologies to patients worldwide. You will be responsible for the coordination, preparation, and maintenance of document packag

Arcetyp LLC is a growing small business that provides a broad range of consulting services to US Federal Government, US Military, and Commercial clients. Services include Management & IT Consulting, Program & Project Management, and Professional & Admin Services. We accept direct hire candidates onl

Arcetyp LLC is a growing small business that provides a broad range of consulting services to US Federal Government, US Military, and Commercial clients. Services include Management & IT Consulting, Program & Project Management, and Professional & Admin Services. We accept direct hire candidates onl

We are seeking an experienced Sr. Regulatory Affairs Specialist to support global regulatory compliance and drive high‑impact submissions. In this role, you’ll lead FDA 510(k)/PMA filings, maintain international registrations, support audits, develop SOPs, and partner closely with technical teams to

Our mission at Oura is to empower every person to own their inner potential. Our award-winning products help our global community gain a deeper knowledge of their readiness, activity, and sleep quality by using their Oura Ring and its connected app. We've helped millions of people understand and imp

Sr. Regulatory Affairs Specialist Position Summary The Sr. Regulatory Affairs Specialist will be Responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations and listings. Ensuring that the company adheres to all relevant laws, regulations, and stan

Job Summary Sr Regulatory Affairs Specialist is an accomplished regulatory professional with a successful work history with leading regulatory initiatives and partnering with Sales and Marketing teams in obtaining domestic and internal regulatory clearances for Masimo products to meet business objec

Arcetyp LLC is a growing small business that provides a broad range of consulting services to US Federal Government, US Military, and Commercial clients. Services include Management & IT Consulting, Program & Project Management, and Professional & Admin Services. We accept direct hire candidates onl

We anticipate the application window for this opening will close on - 31 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to

Regulatory Affairs Specialist manages assigned projects of moderate complexity which include international regulatory activities; on-market compliance reports or assessment of design changes, manufacturing process and labeling changes for regulatory reporting, as assigned. This position requires a p

Join Axon and be a Force for Good. At Axon, we’re on a mission to Protect Life. We’re explorers, pursuing society’s most critical safety and justice issues with our ecosystem of devices and cloud software. Like our products, we work better together. We connect with candor and care, seeking out diver

AMNEAL PHARMACEUTICALS Regulatory Affairs Specialist: With minimal supervision assists with the preparation of high-quality regulatory submissions to the Food and Drug Administration (FDA) as required, within company timelines and in accordance with regulatory guidelines and applicable federal laws.