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.
...a leader in the disaster restoration services, is seeking an Estimator for our Columbus, GA location. The ideal candidate will have residential... ...an estimate for a fire, water or construction loss utilizing Xactimate Estimating software and sometimes Symbility estimating...
...Ascension Saint Thomas Urgent Care is looking for dedicated, compassionate, and experienced Medical Assistant/X-Ray or Radiology Tech to join our dynamic healthcare team in Springfield, TN. FT and PRN opportunities are available! ABOUT ASCESNION SAINT THOMAS URGENT...
...Description Salary: $130,000 - $160,000 a year, commensurate with experience Medical Director for Baltimore City Health Department Sexual Health and Wellness Clinic (SHWC) The Medical Director oversees clinical services at Baltimore City Health Department...
...Job Description Job Description Looking for Tile Installer/Project Manager with 3 years of experience being a lead project manager liningout guys for tile installation, patterns, layouts, directions and more,as well as the ability to install tile on projects as...
Registered Nurse (RN) for the ER Job Summary Mission Community Hospital is currently looking for a Registered Nurse to join their growing and caring team. As a RN for the ER you will be responsible for independently utilizing the nursing process to safely, therapeutically...