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.
Foreign Legal Consultant Falcon Rappaport & Berkman LLP seeks a Foreign Legal Consultant. The job site is located at 1201 Dove Street, Suite 400, Newport Beach, CA 92660. The position requires an L.L.M. with specialization in Business, Taxes, or Finance, and the ability...
...professionals with meaningful career opportunities. We are seeking a Legal Assistant to join our clients team. This is a direct hire... ...Work Environment & Benefits ~ Hybrid work model up to four remote days per month (subject to firm policy). ~ Collaborative, professional...
...an experienced Retail Store Manager in New York to drive sales and develop a high-performing team. Responsibilities include overseeing operations... ...leadership skills. The role offers a competitive salary, commission potential, and comprehensive benefits. #J-18808-Ljbffr...
...Job Description Job Description Senior Audit Associate If you are a Senior Audit Associate with experience, please read on! We are a full service, nationally affiliated public accounting firm located in Tucson, Arizona. Looking for a dynamic Audit Senior Associate...
...unrivaled benefits package, 37.5 hour work week, defined retirement contribution plan, generous PTO, and professional growth. If you are an audit professional that enjoys the work but are looking for a better quality of life, this is an ideal position for you! We are open to...