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.
...packages, and presentations for internal and customer review. Basic Qualifications (Required Skills and Experience): ~ Bachelor of Science degree in Engineering, Computer Science, Data Science, Mathematics, Physics, Chemistry or non-US equivalent qualifications...
Job Overview Cleans and prepares guest rooms by meeting established standards of cleanliness and propriety to assure guest satisfaction and maximize revenues. Responsibilities Retrieves items from shelves and storerooms, sets up cleaning cart with supplies, constantly...
...Job Description Full Charge Bookkeeper/Staff Accountant Job Description Position Summary: This role supports the finance... ...Other duties as assigned. Requirements: Education, Experience and Skills Personal Qualities: # Strong organizational...
...Job Description Job Description Enjoy your career in Travel with this Travel Agent position in this exceptional and highly exciting... ...A background in travel sales will be very helpful. Cruises International (established 1978) sells cruises and leisure travel and is a...
...Job Description Are you interested in an alternative legal career that combines legal expertise, training and sales? Do you... ...the Greater Cincinnati, OH area. As a Blended Practice Area Consultant, you will engage customers in law firms and schools. You will do...