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.
...Overview Gain real-world business, accounting, and financial training that will teach you all aspects of financial management pertaining... ...This position pays an hourly rate of $20.00 / hour. This internship will take place during the Summer of 2026, and will be a full...
...be successfully completed during orientation One supervisory reference in specialty required for consideration No open background check cases or license hits accepted \n Benefits\n ~ High Pay and Bonuses ~ Medical, Dental and Vision Insurance with Day 1 Options...
...basic customer and team member inquiries. Monitor illegal parking, and immediately store vehicles. Interact with guests in a... ...guest keys Predict and communicate traffic flow peaks and lot issues Identify and arrange for extra support for extended...
...We are actively recruiting for a Director of Human Resources in the Los Angeles market. The Director of HR will be responsible for developing, implementing, and overseeing an enterprise-wide human resources strategy across all U.S. and Mexico operations. This role has...
...Velocity Rail Solutionshas been a trusted provider of locomotive fueling services since 1996. We operate under long-term contracts with... ...a full benefits package available after 60 days of employment. Drivers find out our benefit offerings, low deductibles, premiums,we...