Sr. Regulatory Affairs Specialist Locations: Sunnyvale, CA Job Type: On-site, FTE Salary Range: 80K-140K Responsibilities: In this role, you will be part of the regulatory team responsible for proper oversight of medical device development and market introduction. You will work closely with Quality, Engineering, Product Management, Marketing, and Sales teams to perform regulatory pre- and post-market analysis and implement and maintain an ISO 13485 and FDA-compliant Quality Management System. Participate in the preparation and review of regulatory submissions to the US FDA and international (outside the US) regulatory authorities. Support government interactions pertaining to medical device registrations and licensing. Participate in the development of regional regulatory strategy and update strategy based on regulatory changes. FDA 510k and EUA application. Provide regulatory support to cross-functional product development and project teams throughout the product lifecycle. Support regulatory activities required for MDR compliance. Provide regulatory assessment for manufacturing and design changes. Provide regulatory review and approval of change order packets. Support product regulatory intelligence and risk assessments. Assist in maintaining compliance with product post-market requirements. Support post-market regulatory actions taken for the products. Assist in the review of advertising and promotional materials. Support internal and external audits. Ensure compliance with internal procedures and external regulations and standards. Maintain and update quality system procedures. Maintain quality records and other controlled documents. Other Regulatory and Quality duties as assigned. Requirements: Bachelor’s degree in Science, Engineering, Math, a medical field, or an equivalent educational background with a focus on technical writing, scientific methodologies, and problem-solving. A minimum of 5 years of experience in medical device Regulatory Affairs, showcasing a comprehensive understanding of regulatory frameworks. Demonstrated ability to manage small projects, displaying exceptional organization, independence, and outcome-driven focus. Outstanding analytical and communication skills, paired with a strong sense of teamwork and meticulous attention to detail. #J-18808-Ljbffr Ipro Networks Pte. Ltd.
...solutions, is seeking a Sprinkler Service Technician to join our dedicated team. This role focuses on the maintenance, repair, and installation of fire sprinkler systems. Our ideal candidate will be technically skilled, reliable, and committed to ensuring our clients'...
...Mechanic apprentice will assist other automotive mechanics in various duties related to general truck repairs and perform a wide variety of basic truck repairs including component replacement, grease, fluid fills and troubleshooting. 401K with match, vacation, day shift...
...training to unlicensed individuals, enabling them to obtain an insurance license and enter one of the rapidly expanding industries. This role... ...specialized department. # Collaborates closely with the agent or operations manager to determine optimal coverage solutions...
...Level I Voice & Data Technician Plug Into a Career That Keeps Texas Connected! Ready to launch your career in low voltage and structured cabling? This is your chance to get hands-on in a fast-growing, high-demand industry where every cable you pull and every connection...
G&W Electric seeks a skilled Painter I to join our manufacturing team. This role is essential in maintaining the high standards of our production processes, ensuring all products meet our rigorous quality standards before they reach global markets. The Painter I will work...