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 Overview Job Brief: An Illustrator II has a strong artistic background and an eye for appealing visual images. Theyre responsible for creating an image that matches what the client wants and their desired outcome. Illustrators take a concept, idea or message and turn...
...Description: Perkins Coie LLP is looking for a talented and dynamic individual to join our team as an experienced Senior Corporate Paralegal with our Emerging Companies & Venture Capital practice group. The Paralegal will, under minimal supervision, assist lawyers...
...Were looking for a detail-focused Entry-Level Documentation Quality Reviewer to join New Paradigm Staffing ensuring healthcare documents meet quality and compliance standards. This role is perfect for someone who enjoys reviewing text and identifying errors. Youll...
...Part-Time Nannies Needed Lake Forest (Temporary Role) A welcoming family in Lake Forest is seeking a part time, reliable nannyto help care for their three children (ages 6, 5, and almost 2). This is a temporary role running through January 2026 . &##128197; Schedules...
JOB REQUIREMENTS: To include but not limited to Sort and rinse dirty dishes, glass, tableware and other cooking utensils and place them in racks to send through dish machine. Fill/empty soak tubs with cleaning/sanitizing solutions. Sort and stack clean dishes...