Regulatory Affairs Specialist Jobs in United States

The Senior Regulatory Affairs Specialist is responsible for independently supporting Rhythmlink Regulatory Affairs in the development, implementation, and maintenance of domestic and international medical device regulatory compliance activities. This role serves as a senior individual contributor an

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

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

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

Pivotal is the leader in the emerging market of electric Vertical Takeoff and Landing (eVTOL) aircraft. We design, develop, and manufacture light eVTOL aircraft and are renowned for the BlackFly aircraft the world's first light eVTOL to fly manned missions and enter the consumer market. Efficient, c

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

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

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

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

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

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

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

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

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. At Integer, our values are embedded in everything we do. Customer We focus on our customers’ success Innovation We create

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.

At CJ Schwan’s, we don’t just make food — we help create moments that matter. From kids devouring pizza after soccer practice, to students laughing over dumplings in a cafeteria, to families enjoying pie during the holidays, our team members play an important role in bringing those everyday moments

At Hologic, women's health is at the heart of everything we do. Our Regulatory Affairs team plays a vital role in bringing innovative, compliant, and safe medical technologies to market, helping advance early detection, diagnosis, and treatment solutions that improve the lives of women around the wo

We anticipate the application window for this opening will close on - 5 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