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.
Reproductive Endocrinologist (REI Physician) Full-Time Houston & Austin, Texas Compensation: Competitive salary + performance incentives (negotiable based on experience) About Pozitivf Fertility Pozitivf Fertility was founded on a bold, human belief: the ability...
Description We're seeking a Digital Marketing Intern to join our Strategic Projects team and gain hands-on experience driving visibility,... ...and growth across our defense and technology verticals. This internship is designed for someone who wants meaningful, real-world marketing...
...Our Medical Specialists are at the forefront of engaging Allergists and other key customers. We need someone who is highly proficient in... ...leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit For other...
**Description**SAIC is seeking **Engineering Interns** to join our team of qualified, diverse, and highly motivated individuals located in **Crane, IN** .**This position is primarily on-site in Crane, IN, with the possibility of hybrid work schedule at a later date.*...
...Job Description Job Description We are seeking a motivated individual to join our team as a Solar Installer and Technician. In this role, you will assist our experienced solar installers with the installation of solar panels and related equipment. The ideal candidate...