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.
...professional who loves turning complex business needs into engaging training experiences? Fleet Farm is looking for a talented Instructional Designer to develop innovative learning programs for our stores, distribution centers and corporate teams. What Youll Do:...
Chemical Process Engineer Location Chattanooga, TN (City Center/Downtown area) : What We're Looking For: As a Chemical Process Engineer at Barge Design Solutions , you will play a key role in shaping innovative, high-impact solutions across a variety of industrial...
...Job Description Job Description Description Location Name: The Ritz-Carlton Bal Harbour, Miami Location Address: 10295 Collins Ave Bal Harbour, FL 33154 Position: Valet Attendant (Fulltime) Shift Times: (Depending on Staffing Needs) Overnight Shift: 11:...
...expereince. Train to be an IR and Cath Lab Special Procedures Technologist! Newly graduated and current Radiology Technologists are encouraged... ...to building a new development enterprise and looking for creative, collaborative leaders who are passionate about using their skills...
...We are hiring a Social Worker for one of our clients in Mercerville, NJ. Job Description: Note: Once a candidate is selected... ...be in a professional location such as a senior housing, nursing home, etc. Examples of work: Receives, screens, reviews...