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.
...Job Description Job Description This is a remote position. We are looking for a Junior Web Developer to join our team and contribute to the creation of high-quality web applications. The ideal candidate should be passionate, eager to learn, and thrive in a collaborative...
...Posted 12/19/2025Job Descriptionback to topJob Description Continue your career as a cybersecurity professional with BAE Systems, supporting and protecting information systems critical to national security at one of the leading companies in Aerospace and Defense...
...Description Introduction Apply for our Maintenance Mechanic II opening with Rio Grande Regional Hospital today and find out what it truly means to be a part of the HCA Healthcare team. Benefits Rio Grande Regional Hospital, offers a total rewards package...
...Job Title: Order Puller - Electric Pallet Jack & Reach Truck Forklift Operator. Location: Lancaster, TX. Pay: $17.00 - $19.00 per hour. Available Shifts: ~1st Shift: Monday-Friday + OT | 6:00 AM-2:30 PM | $17.50/hr. Company Overview: Join a leading...
A leading healthcare company in Pleasanton, CA is seeking a motivated Software Engineer specializing in Next Generation Sequencing Bioinformatics. The role involves designing and optimizing algorithms, collaborating with cross-functional teams, and developing high-performance...