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.
...openings industry wide. You have your Class A CDL license but no experience yet. Most carriers wont give you a chance without experience,... ...for OTR training for just 2 weeks of paid training. Training pay is $350 for the first 2 weeks only. After trainingthen you...
...Assistant Manager The Assistant Manager is responsible for assisting and consulting the Store Manager and regarding overall operations and... ...Assist the Store Manager in controlling the assets of Hibbett I City Gear Consults with Store Manager in establishing action...
...equipment properly. Troubleshoots automated dispensing systems as needed. Education Requirement: Required Education: -High School Diploma/GED. Preferred Education: -N/A Required Certifications & Licensure: -Must be licensed to practice as a Registered Pharmacy Technician...
...providers are properly credentialed, privileged, and enrolled, and in compliance with federal, state, and organizational credentialing policies.... ...proficiency with web-based applications and the Microsoft Office suite, including Outlook, Word, Excel and PowerPoint....
...management firm in San Diego is seeking a strategic, results-driven Vice President to shape and execute priorities in the Office of the CEO. The ideal candidate will be responsible for overseeing daily operations and driving high-impact initiatives. This role requires a...