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.
Looking for a boys and girls basketball coach for grades 3rd-8th.Practices are 2 days a week from 3 pm - 5 p.m.Wage Range The rate of pay offered to the selected candidate is based on internal pay policy and budget. New hires are commonly paid at the minimum of the wage...
...Overview Job Title: Medical Assistant Location: Chicago Lawn, Chicago, IL Compensation... ...procedure rooms. Maintain monthly par-levels of all supplies and medications (e.g.,... ...personnel any delays in a patient's visit from entry to exit. Qualifications...
...Nurse Supervisor Career Opportunity *Day And Night Shift* Supervisor Positions Available 10k Sign on Bonus! Leading with Heart: Your Journey Starts Here Seeking a career that's both personally enriching and professionally rewarding, close to home...
IntroductionCurrently, we are looking for a highly experienced, team-oriented sales professional to partner with our consulting team as we continue to grow our market. The Oracle Associate Partner will play an integral role on our Commercial Sales team to grow local presence...
...product expertise, and an authentic connection with our customers. Were ready to take the next step in our journey becominga content powerhouse. Thats where you come in. Position Summary We are seeking atop-tier Social Media & Content Strategy...