Description. Represents the Regulatory Affairs function in project teams and leads regulatory projects in accordance with established timelines to meet corporate objectives. Develops and executes sound regulatory strategies to support business goals. Oversees and ensures compliance with state, federal, and international medical device regulations and overall regulatory departmental objectives for new and existing products. In addition, this posit...
Overview. Position Summary. Responsible to manage pre-market regulatory activities required to maintain compliance to US FDA, Health Canada and EU IVD Regulations (EU) 217/46, as well as other country regulatory agencies. Represents regulatory on design teams, prepares regulatory plans, authors US FDA 510(k)s, Health Canada license and EU Notified Body submissions and interfaces with these agencies through submission completion. Acts as reviewe...
Trumbull, Connecticut. Full Time. This position is with our Consumer Brands business unit - where we empower our employees to bring the best Laundry & Home Care and Hair products to people around the world. Dare to learn new skills, advance in your career and make an impact at our company. What You´ll Do. This position will manage all regulatory affairs activities for Laundry and Dish categories in the US. This includes labeling, product developm...
Job Title. Principal Regulatory Affairs Specialist. Job Description. As a critical member of the Philips Ultrasound- Regulatory Affairs Organization, the Principal Regulatory Affairs Specialist will lead and provide regulatory oversight for critical new product development projects, ensuring our state-of-the-art Ultrasound Products meet FDA, and other governmental agency/notified body Regulatory Compliance standards/requirements. Your Role. Leads...
MAJOR DUTIES AND RESPONSIBILITIES. Responsibilities will include, but not be limited to. Prepare and submit global regulatory applications that support clinical research and marketing approvals in accordance with the company’s strategic objectives. Formulate and implement regulatory strategy, provide guidance, resolve complex issues related to assigned projects, and assure compliance with timelines and milestones to meet business needs. Work dire...
Job Title. Principal Regulatory Affairs Specialist. Job Description. The Principal Regulatory Affairs Specialist will develop and execute the regulatory strategy for new product development, design changes, and field safety corrections, with a primary focus on Software as a Medical Device (SaMD) for our Sleep & Respiratory Care products in the U.S., EU, and Rest of World products. Your Role. Author 510K submissions, pre-sub documents, EUMDR tech ...
