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.
...Our client, a successful apparel company, is looking for a Graphic Design Associate/Assistant to join their team in NYC! Responsibilities Design and develop original prints and graphics in a high-volume, fast-paced setting. Take artwork from initial concept through...
...# Experience and working knowledge in irrigation repair and/or installation # Training or education in turf grass management, horticulture or agronomy Physical Requirements: Frequent and repeated bending, stooping, and kneeling. Working with arms extended above...
...About the job Cable Assembler Top Gun Staffing Group is proud to partner with a global leader in advanced technology solutions... ...Communicate effectively by listening, clarifying, and recording data with precision. What You Bring ~ High school diploma or...
Role Overview USPS is accepting applications for PSE Mail Processing Clerks nationwide. This role is vital to ensuring the timely and accurate processing of mail. USPS provides comprehensive training to help you succeed, even if you have no prior experience. Position Details...
...Pharmaceutical Sales Associate (Entry-Level) The Pharmaceutical Sales Associate is a critical role to maintain relationships within healthcare offices to supply patient materials and vouchers/samples, as well as provide in-office education as required. The Pharmaceutical...