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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Job Details. Job Description. Location. Onsite Irvine, CA. Contract. 1-Year Contract with potential for extension. Company. J&J Vision. About the Opportunity. We re supporting Johnson & Johnson Vision in hiring a. Senior Regulatory Affairs Specialist. for a one-year contract role with strong potential to extend. This is a great opportunity to join a growing team at one of the most respected and innovative surgical vision companies in the world. T...
About PENTAX Medical. Our mission is to improve the standard of patient care and quality of healthcare delivery by providing the best endoscopic products and services with a focus on QUALITY, CLINICALLY RELEVANT INNOVATION, and SIMPLICITY. Through leading edge R&D and manufacturing, PENTAX Medical provides endoscopic imaging devices and solutions to the global medical community. Position Opening: Senior Regulatory Affairs Specialist. Why JOIN Us....
Senior Regulatory Affairs Specialist. Direct Hire Full-Time Role. Salary Range. $129,000 - $147,000 per year. Location. Santa Clara, CA - Hybrid Role. Duties and Responsibilities. Prepare regulatory submissions to support product commercialization (e.g., 510(k), CE Mark Technical Files, international submissions). Maintain existing regulatory approvals, clearances, and documentation. Manage regulatory projects aligned with key strategic and comme...
Senior Regulatory Affairs Specialist. Direct Hire Full-Time Role. Salary Range. $129,000 - $147,000 per year. Location. Santa Clara, CA - Hybrid Role. Duties and Responsibilities. Prepare regulatory submissions to support product commercialization (e.g., 510(k), CE Mark Technical Files, international submissions). Maintain existing regulatory approvals, clearances, and documentation. Manage regulatory projects aligned with key strategic and comme...
Job Title. Sr. Regulatory Affairs Specialist / Manager. Position Type. Full time. Location. Sunnyvale, California, United States. Team. Regulatory Affairs. Salary Range. 160k-165k. Job Description. We are seeking a highly motivated and detail. Sr. Regulatory Affairs Specialist / Manager. Key Responsibilities. In this role, you will be part of the regulatory team responsible for proper oversight of medical device development and market introductio...
About PENTAX Medical. Our mission is to improve the standard of patient care and quality of healthcare delivery by providing the best endoscopic products and services with a focus on QUALITY, CLINICALLY RELEVANT INNOVATION, and SIMPLICITY. Through leading edge R&D and manufacturing, PENTAX Medical provides endoscopic imaging devices and solutions to the global medical community. Position Opening. Senior Regulatory Affairs Specialist. Why JOIN Us...
Job Title. Senior Regulatory Affairs Specialist. Pay Rate. $65 to $80/HR. Duration. 12 months. Location. Newton, MA. Shift - 8 AM -5 PM. This position is for the. Healthcare Diagnostics. division. We are looking for a. Senior Regulatory Affairs Specialist. Formulate and execute activities associated with. regulatory submissions. of a novel. robotic medical device. in the. US. market, as well as markets outside of the US (e.g. Europe, Asia. ). In ...
Senior Regulatory Affairs SpecialistWho We AreNeuroLogica, a Samsung company, serves as the global headquarters and manufacturer for Samsung Healthcare’s Computed Tomography (CT) business, delivering innovative mobile CT solutions used in leading healthcare institutions worldwide. Our technologies help providers enhance patient care, improve satisfaction, and increase workflow efficiency across diverse clinical environments.As part of Samsung Hea...
Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona’s products pro...
Regulatory Affairs SpecialistPosition SummaryThe Regulatory Affairs Specialist ensures global compliance of all cosmetic and OTC (Over-the-Counter) products with applicable regulatory requirements. This position supports and manages regulatory activities across product development, manufacturing, labeling, and market expansion. Working cross-functionally with R&D, Quality, Marketing, and Operations, the Specialist maintains the regulatory integri...
Regulatory Affairs Manager – Clinical & Nonclinical Submissions. Location. Fully Remote. Industry. Biotechnology / Pharmaceutical. Duration. 10 months (potential to extend or convert). Pay. $60-70/hour. Our client is a leading biotechnology company known for developing breakthroughs in rare and specialty diseases. They combine cutting-edge science with a mission-driven culture, offering an environment where regulatory professionals can directly i...
