What does a Senior Regulatory Affairs Specialist Do?
The Senior Regulatory Affairs Specialist assists in developing procedures to ensure regulatory compliance. Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Being a Senior Regulatory Affairs Specialist typically reports to a manager or head of a unit/department. May require an advanced degree. Working as a Senior Regulatory Affairs Specialist typically requires 4 to 7 years of related experience. Contributes to moderately complex aspects of a project. Work is generally indepe ...ndent and collaborative in nature.More Show Less
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The Senior Regulatory Affairs Specialist will support and carry out the regulatory strategy and other regulatory aspects of product development and processes for the Biofourmis pharma partnerships and DTx algorithms. Reporting to the SVP of Q&R, the Senior Regulatory Affairs Specialist will have responsibility for. Supporting and maintaining the pharma partnership product strategies and deliverables within the assigned project teams. Managing com...
Senior Regulatory Affairs Specialist. . WHO WE ARE. NeuroLogica Corp., a subsidiary of Samsung Electronics Co. Ltd., develops, manufactures, and markets innovative imaging technologies and is committed to delivering fast, easy, and accurate diagnostic solutions to healthcare providers. NeuroLogica is the global corporate headquarters and manufacturer of mobile computed tomography, and is also the US headquarters for sales, marketing, service and ...
Job Details. Description. Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist. Remote work options may be considered on a case-by-case basis and if approved by the Company. Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First. " culture dr...
POSITION. Senior Regulatory Affairs Specialist. . FULL-TIME/PART-TIME. Full Time. . LOCATION. Hybrid. . React Health is a fast paced, growth oriented, manufacturer and distributor of medical equipment serving the respiratory, sleep and cardiology patients, caregivers, physicians, and providers. React Health sells and supports its product and services in the acute-care, non-acute and home medical equipment markets. React Health has built a model t...
Pulmonx. is looking for an experienced. Sr Regulatory Affairs Specialist. to join our dynamic Regulatory Affairs Team. Not sure who Pulmonx is and how our Zephyr valves help people to breathe better. Check out some of the videos on our YouTube Channel: https://www.youtube.com/@zephyr-by-pulmonx. Responsibilities and capabilities. Support Product Development & Registration. . Provides regulatory input and technical guidance on global regulatory re...
About Us. . At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the tech...
Our client is seeking a skilled and dynamic Senior Regulatory Affairs Specialist for a temporary position. As a pivotal member of their team, you will play a crucial role in ensuring compliance with medical device regulations, particularly the EU Medical Device Regulation (MDR). The ideal candidate for the Senior Regulatory Affairs Specialist role will possess 3-5 years of experience in regulatory affairs, with a strong background in EU MDR, regu...
StimLabs is looking to hire a Senior Regulatory Affairs Specialist to join our Regulatory team. This role would report directly to our Chief Regulatory and Quality Officer. The ideal candidate has extensive experience partnering with R&D and marketing to review marketing materials for HCT/P and devices. Although this person does not have to work out of our Roswell, GA office, ideally this person would be able to come into the office a minimum of ...
OrthAlign, Inc. a Smart Technology, growing medical device company, has an immediate opening for a. Senior Regulatory Affairs Specialist. responsible for. implementing regulatory strategies, assisting with the preparation, organization, and maintenance of documentation sufficient to ensure regulatory compliance of all new and existing products. In this role, you will prepare product submissions, handle license renewals, and provide periodic upda...
Company Overview. Verathon. is a global medical device company focused on supporting customers by being their trusted partner, delivering high-quality products that endure over time and ensure clinical and economic utility. Two areas where Verathon has significantly impacted patient care, and become the market leader in each, are bladder volume measurement and airway management. The company’s BladderScan portable ultrasound and GlideScope video l...
Overview. Werfen. Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than...
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